Back to resultsEpidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Capillary blood sample
Data collection
Sponsored by
About this trial
This is an interventional other trial for Malaria focused on measuring Saharan Western Africa, Epidemiology, Post-Approval Programme study, Malaria, Burden of Disease Study
Eligibility Criteria
Inclusion Criteria:
- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female equal or more than 6 months of age and less than 10 years of age at the time of survey.
- Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.
Exclusion Criteria:
- Child in care.
- Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Overall Study Group
Arm Description
Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.
Outcomes
Primary Outcome Measures
Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center
PFP = measurement of parasite prevalence (PP) by center according to joint technical expert group (JTEG). Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). A subject was defined as infected by P. falciparum parasitemia, if at least two of the subject's blood slide readings were positive for the corresponding parasitemia.
Number of Subjects With Malaria Control Interventions (MCIs), Overall
MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)
Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status
MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)
Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category available for 'Use of Traditional Repellents over 7 days': Missing/No - There was only one category available for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category for 'Use of Insecticide spray over 7 days': Missing/No and 'Use of Traditional Repellents over 7 days': Missing/No - The reference category ('2') for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days, 'Use of Indoor residual spray - numbers of months ago': 9, 'Use of Commercial Repellents over 7 days': Missing/No - There were not enough values in the reference category ('<5') to compute the OR for HS. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), UMc > 7D, UIs >7D, UCR > 7D, UTR > 7D, Una >7D.
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days and 'How many holes of that size': ≥5. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Secondary Outcome Measures
Number of Subjects With Other Medical History Characteristics, Overall
The medical history characteristics were as follows: -subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated Bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS).
Number of Subjects by Age, According to P. Falciparum Infection Status
The annual age extended over a 0 year-9 years range. The age characteristics were summarized by P. falciparum infection status.
Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status
The JTEG categorisation referred to the distribution of subjects by different age groups: 6 months to 4 years of age inclusive (0.5Y-4Y category) and 5 to 9 years of age inclusive (5-9Y category), tabulated according to P. falciparum infection status.
Number of Subjects by Gender, According to P. Falciparum Infection Status
The gender characteristics were summarized by P. falciparum infection status.
Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers
Other Plasmodium species included: P. Malariae, P. Vivax, P. Ovale with Negative and Positive results. A subjects was defined as infected by a specified parasitemia if at least two of the subject's blood slide readings were positive for the corresponding parasitemia. The results were tabulated according to JTEG age categorisation.
Number of Subjects With Anti-malarial Therapy, Overall
Anti-malarial therapy included Malaria treatment (MT) in past 14 days, Other medication (OM) in past 14 days and Malaria hospitalization (MH) in the last 3 months.
Number of Days With Therapy, Overall
The duration of anti-malarial therapy referred to the exact number of days of malaria treatment (EDMT) and the number of days of other medication (DOM). Note: * In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.
Days of Malaria Treatment, Overall
This endpoint presents results per total centers and across all age categories.
Number of Subjects With Fever, Overall
Characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever* at visit (F* at V). Note: *Fever set to Yes if temperature recorded at visit after axillary conversion was ≥ 37.5 ◦C.
Days With Fever, Overall
This endpoint presents results per total centers and across all age categories.
Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall
The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house.
Descriptive Statistics for Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall
The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house (PLSPH).
Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center
The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center
The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house (PLSPH). Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Number of Subjects With P. Falciparum by Situation Area, Overall
The malaria prevention and risk factor characteristics for this endpoint were the following: Situation area (rural, urban, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants.
Number of Subjects With Different P. Falciparum Densities by Situation Area and Center
The malaria prevention and risk factor characteristics were the following: Situation area (urban, rural, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall
The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Note: *Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. % Closed water source (piper water, tube well, dug well, protected well); Open water source (unprotected well, spring water, rainwater, tanker truck, surface water).
Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center
The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Closed water source = pipe water, tube well, dug well, protected well; Open water source = unprotected well, spring water, rainwater, tanker truck, surface water. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01954264
Brief Title
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Official Title
Epidemiology Study of Malariometric Determinants in Selected Post-Approval Programme Study Sites in Sub-Saharan Western Africa
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 19, 2013 (Actual)
Primary Completion Date
November 22, 2013 (Actual)
Study Completion Date
November 25, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study is designed to characterise P. falciparum transmission intensity in subjects aged ≥6 months and <10 years by measurement of P. falciparum parasite prevalence, and to estimate the use of malaria control interventions at some centres selected for the EPI-MAL-002 and EPI-MAL-003 studies in sub-Saharan Western Africa.
Detailed Description
Two subsequent studies (EPI-MAL-002 and EPI-MAL-003) are planned to monitor vaccine safety prior to and after implementation of the RTS,S/AS01 candidate malaria vaccine. EPI-MAL-002 will take place before RTS,S is authorised and EPI-MAL-003 will start when RTS,S is registered and authorised in the country. A cross-sectional survey at peak transmission will provide by-site point estimates of Parasite prevalence (PP) and malaria control measure coverage in the areas participating in EPI-MAL-002/-003. EPI-MAL-006 will be conducted in advance of EPI-MAL-002/-003 in order to assess PP and malaria control measures to inform enrollment in these studies. The age group for enrollment (≥6 months - <10 years) will permit analysis of PP according to the World Health Organization (WHO) definition (2-9 years) and by the Joint Technical Expert Group (JTEG) suggested age (<5 years).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Saharan Western Africa, Epidemiology, Post-Approval Programme study, Malaria, Burden of Disease Study
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2421 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Overall Study Group
Arm Type
Other
Arm Description
Subjects aged between 6 months to 9 years old, who were infected or not infected with Plasmodium falciparum parasite. Infection status was assessed using a blood smear slide and determined using microscopy.
Intervention Type
Procedure
Intervention Name(s)
Capillary blood sample
Intervention Description
Capillary blood sample (up to 200µL) for determination of PP (blood slides).
Intervention Type
Other
Intervention Name(s)
Data collection
Intervention Description
Prospective data collection at the study visit by the internet based Electronic Case Report Form (eCRF)
Primary Outcome Measure Information:
Title
Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center
Description
PFP = measurement of parasite prevalence (PP) by center according to joint technical expert group (JTEG). Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). A subject was defined as infected by P. falciparum parasitemia, if at least two of the subject's blood slide readings were positive for the corresponding parasitemia.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects With Malaria Control Interventions (MCIs), Overall
Description
MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status
Description
MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso
Description
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category available for 'Use of Traditional Repellents over 7 days': Missing/No - There was only one category available for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso
Description
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category for 'Use of Insecticide spray over 7 days': Missing/No and 'Use of Traditional Repellents over 7 days': Missing/No - The reference category ('2') for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal
Description
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days, 'Use of Indoor residual spray - numbers of months ago': 9, 'Use of Commercial Repellents over 7 days': Missing/No - There were not enough values in the reference category ('<5') to compute the OR for HS. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), UMc > 7D, UIs >7D, UCR > 7D, UTR > 7D, Una >7D.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal
Description
MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days and 'How many holes of that size': ≥5. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Secondary Outcome Measure Information:
Title
Number of Subjects With Other Medical History Characteristics, Overall
Description
The medical history characteristics were as follows: -subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated Bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS).
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects by Age, According to P. Falciparum Infection Status
Description
The annual age extended over a 0 year-9 years range. The age characteristics were summarized by P. falciparum infection status.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status
Description
The JTEG categorisation referred to the distribution of subjects by different age groups: 6 months to 4 years of age inclusive (0.5Y-4Y category) and 5 to 9 years of age inclusive (5-9Y category), tabulated according to P. falciparum infection status.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects by Gender, According to P. Falciparum Infection Status
Description
The gender characteristics were summarized by P. falciparum infection status.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers
Description
Other Plasmodium species included: P. Malariae, P. Vivax, P. Ovale with Negative and Positive results. A subjects was defined as infected by a specified parasitemia if at least two of the subject's blood slide readings were positive for the corresponding parasitemia. The results were tabulated according to JTEG age categorisation.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects With Anti-malarial Therapy, Overall
Description
Anti-malarial therapy included Malaria treatment (MT) in past 14 days, Other medication (OM) in past 14 days and Malaria hospitalization (MH) in the last 3 months.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Days With Therapy, Overall
Description
The duration of anti-malarial therapy referred to the exact number of days of malaria treatment (EDMT) and the number of days of other medication (DOM). Note: * In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Days of Malaria Treatment, Overall
Description
This endpoint presents results per total centers and across all age categories.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects With Fever, Overall
Description
Characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever* at visit (F* at V). Note: *Fever set to Yes if temperature recorded at visit after axillary conversion was ≥ 37.5 ◦C.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Days With Fever, Overall
Description
This endpoint presents results per total centers and across all age categories.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall
Description
The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Descriptive Statistics for Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall
Description
The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house (PLSPH).
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center
Description
The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center
Description
The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house (PLSPH). Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects With P. Falciparum by Situation Area, Overall
Description
The malaria prevention and risk factor characteristics for this endpoint were the following: Situation area (rural, urban, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects With Different P. Falciparum Densities by Situation Area and Center
Description
The malaria prevention and risk factor characteristics were the following: Situation area (urban, rural, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall
Description
The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Note: *Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. % Closed water source (piper water, tube well, dug well, protected well); Open water source (unprotected well, spring water, rainwater, tanker truck, surface water).
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
Title
Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center
Description
The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Closed water source = pipe water, tube well, dug well, protected well; Open water source = unprotected well, spring water, rainwater, tanker truck, surface water. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.
Time Frame
At Epoch 1 (Survey visit) (approximately 35 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female equal or more than 6 months of age and less than 10 years of age at the time of survey.
Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the child.
Exclusion Criteria:
Child in care.
Current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Nouna
Country
Burkina Faso
Facility Name
GSK Investigational Site
City
Ouagadougou
Country
Burkina Faso
Facility Name
GSK Investigational Site
City
Dakar
Country
Senegal
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below).
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below).
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=19801
Citations:
PubMed Identifier
28166794
Citation
Diallo A, Sie A, Sirima S, Sylla K, Ndiaye M, Bountogo M, Ouedraogo E, Tine R, Ndiaye A, Coulibaly B, Ouedraogo A, Faye B, Ba EH, Compaore G, Tiono A, Sokhna C, Ye M, Diarra A, Bahmanyar ER, De Boer M, Pircon JY, Usuf EA. An epidemiological study to assess Plasmodium falciparum parasite prevalence and malaria control measures in Burkina Faso and Senegal. Malar J. 2017 Feb 6;16(1):63. doi: 10.1186/s12936-017-1715-1.
Results Reference
derived
Links:
URL
http://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
200187
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
200187
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
200187
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
200187
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
200187
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
200187
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
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