Back to resultsEvaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
Primary Purpose
Intermittent Preventive Treatment In Pregnancy (IPTp)
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Azithromycin plus chloroquine
sulfadoxine-pyrimethamine
Sponsored by
About this trial
This is an interventional prevention trial for Intermittent Preventive Treatment In Pregnancy (IPTp) focused on measuring P. falciparum malaria, IPTp
Eligibility Criteria
Inclusion Criteria:
- Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by ultrasound).
- Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects <18 years of age.
- Subjects who are willing to and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects who are available for follow up at delivery and on 28 days post delivery.
Exclusion Criteria:
- Age <16 years old or >35 years old.
- Multiple gestations as per the ultrasound at screening.
- Clinical symptoms of malaria.
- Hemoglobin < 8 g/dL (at enrollment).
- Any condition requiring hospitalization at enrollment.
- History of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability.
- Inability to tolerate oral treatment in tablet form.
- Known allergy to the study drugs (azithromycin, chloroquine, and sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides.
- Requirement to use medication during the study that might interfere with the evaluation of the study drug eg, trimethoprim-sulfamethoxazole use in subjects positive for HIV infection.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
- Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
- Known severe Sickle Cell (SS) disease or Sickle Hemoglobin C (SC) anemia.
- Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death.
Sites / Locations
- Centre de Santé d'AHOUANSORI-AGUE
- Hôpital Bethesda
- Siaya District Hospital
- Zomba Central Hospital
- Teule Hospital
- Bugando Medical Centre
- Nyamagana District Hospital, c/o National Institute for Medical Research, Mwanza Centre
- Nyamagana District Hospital
- Mulago Hospital Complex
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AZCQ
SP
Arm Description
Azithromycin/chloroquine
sulfadoxine-pyrimethamine (Fansidar)
Outcomes
Primary Outcome Measures
Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Secondary Outcome Measures
Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Percentage of Neonates With LBW (<2500 g) in ITT Population
LBW was defined as live birth weight <2500 g (up to and including 2499 g).
Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population
LBW was defined as live birth weight <2500 g (up to and including 2499 g).
Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation
Severe maternal anemia was defined as Hb <8 g/dL.
Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation
Anemia was defined as Hb <11 g/dL.
Percentage of Participants With Placental Parasitemia at Delivery
Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.
Percentage of Participants With Placental Malaria at Delivery Based on Histology
Participants positive for placental malaria at delivery were evaluated based on placental histology.
Sexually Transmitted Infection (STI) Episodes Per Participant
Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results).
Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation
Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.
Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.
Percentage of Neonates With Congenital Abnormalities at Birth
Neonates with congenital abnormalities at birth were noted.
Percentage of Perinatal or Neonatal Deaths
Percentage of perinatal or neonatal deaths were noted.
Birth Weight of Live Borne Neonate
Birth weight of live borne neonates were calculated in grams.
Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery
This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever >37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria.
Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery
This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results).
Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation
This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.
Percentage of Participants With Peripheral Parasitemia at Delivery
This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.
Percentage of Participants With Cord Blood Parasitemia at Delivery
This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.
Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation
Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38.
Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation
Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.
Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation
Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.
Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation
Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used.
Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation
Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test.
Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.
Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining.
Percentage of Neonates With Ophthalmia Neonatorum at Birth Period
Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge.
Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery
Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.
Percentage of Participants With Pre-eclampsia From Week 20 to Delivery
Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection.
Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae
This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.
Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.
Full Information
NCT ID
NCT01103063
First Posted
April 7, 2010
Last Updated
May 14, 2015
Sponsor
Pfizer
Collaborators
London School of Hygiene and Tropical Medicine, Medicines for Malaria Venture
1. Study Identification
Unique Protocol Identification Number
NCT01103063
Brief Title
Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
Official Title
A Phase 3, Open Label, Randomized, Comparative Study To Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
London School of Hygiene and Tropical Medicine, Medicines for Malaria Venture
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.
Detailed Description
After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Preventive Treatment In Pregnancy (IPTp)
Keywords
P. falciparum malaria, IPTp
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2891 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZCQ
Arm Type
Experimental
Arm Description
Azithromycin/chloroquine
Arm Title
SP
Arm Type
Active Comparator
Arm Description
sulfadoxine-pyrimethamine (Fansidar)
Intervention Type
Drug
Intervention Name(s)
Azithromycin plus chloroquine
Intervention Description
combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
Intervention Type
Drug
Intervention Name(s)
sulfadoxine-pyrimethamine
Other Intervention Name(s)
Fansidar
Intervention Description
Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
Primary Outcome Measure Information:
Title
Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
Description
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Time Frame
Approximately 40 weeks of gestational age
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population
Description
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Time Frame
Approximately 40 weeks of gestational age
Title
Percentage of Neonates With LBW (<2500 g) in ITT Population
Description
LBW was defined as live birth weight <2500 g (up to and including 2499 g).
Time Frame
Approximately 40 weeks of gestational age
Title
Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population
Description
LBW was defined as live birth weight <2500 g (up to and including 2499 g).
Time Frame
Approximately 40 weeks of gestational age
Title
Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation
Description
Severe maternal anemia was defined as Hb <8 g/dL.
Time Frame
At 36-38 weeks of gestation.
Title
Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation
Description
Anemia was defined as Hb <11 g/dL.
Time Frame
At 36-38 weeks of gestation.
Title
Percentage of Participants With Placental Parasitemia at Delivery
Description
Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.
Time Frame
Approximately 40 weeks of gestational age
Title
Percentage of Participants With Placental Malaria at Delivery Based on Histology
Description
Participants positive for placental malaria at delivery were evaluated based on placental histology.
Time Frame
Approximately 40 weeks of gestational age
Title
Sexually Transmitted Infection (STI) Episodes Per Participant
Description
Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results).
Time Frame
Approximately 40 weeks of gestational age .
Title
Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation
Description
Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Time Frame
Approximately 40 weeks of gestational age.
Title
Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.
Description
Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.
Time Frame
Baseline, at 36-38 weeks of gestation.
Title
Percentage of Neonates With Congenital Abnormalities at Birth
Description
Neonates with congenital abnormalities at birth were noted.
Time Frame
Approximately 40 weeks of gestational age.
Title
Percentage of Perinatal or Neonatal Deaths
Description
Percentage of perinatal or neonatal deaths were noted.
Time Frame
Day 28 after delivery.
Title
Birth Weight of Live Borne Neonate
Description
Birth weight of live borne neonates were calculated in grams.
Time Frame
Approximately 40 weeks of gestational age.
Title
Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery
Description
This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever >37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria.
Time Frame
Approximately 40 weeks of gestational age
Title
Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery
Description
This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results).
Time Frame
Approximately 40 weeks of gestational age
Title
Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation
Description
This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.
Time Frame
At 36-38 weeks of gestation
Title
Percentage of Participants With Peripheral Parasitemia at Delivery
Description
This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.
Time Frame
Approximately 40 weeks of gestational age
Title
Percentage of Participants With Cord Blood Parasitemia at Delivery
Description
This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.
Time Frame
Approximately 40 weeks of gestational age
Title
Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation
Description
Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38.
Time Frame
Upto 36-38 weeks of gestation
Title
Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation
Description
Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.
Time Frame
At 36-38 weeks of gestation
Title
Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation
Description
Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.
Time Frame
At 36-38 weeks of gestation
Title
Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation
Description
Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used.
Time Frame
At 36-38 weeks of gestation
Title
Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation
Description
Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test.
Time Frame
At 36-38 weeks of gestation
Title
Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.
Description
Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining.
Time Frame
At 36-38 weeks of gestation
Title
Percentage of Neonates With Ophthalmia Neonatorum at Birth Period
Description
Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge.
Time Frame
Approximately 40 weeks of gestational age
Title
Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery
Description
Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.
Time Frame
Up to approximately 40 weeks of gestational age
Title
Percentage of Participants With Pre-eclampsia From Week 20 to Delivery
Description
Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection.
Time Frame
From Week 20 to approximately 40 weeks of gestational age
Title
Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae
Description
This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.
Time Frame
Visits 6 and 7
Title
Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
Description
This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.
Time Frame
Visits 6 and 7
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by ultrasound).
Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects <18 years of age.
Subjects who are willing to and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Subjects who are available for follow up at delivery and on 28 days post delivery.
Exclusion Criteria:
Age <16 years old or >35 years old.
Multiple gestations as per the ultrasound at screening.
Clinical symptoms of malaria.
Hemoglobin < 8 g/dL (at enrollment).
Any condition requiring hospitalization at enrollment.
History of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability.
Inability to tolerate oral treatment in tablet form.
Known allergy to the study drugs (azithromycin, chloroquine, and sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides.
Requirement to use medication during the study that might interfere with the evaluation of the study drug eg, trimethoprim-sulfamethoxazole use in subjects positive for HIV infection.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
Known severe Sickle Cell (SS) disease or Sickle Hemoglobin C (SC) anemia.
Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Centre de Santé d'AHOUANSORI-AGUE
City
Cotonou
Country
Benin
Facility Name
Hôpital Bethesda
City
Cotonou
Country
Benin
Facility Name
Siaya District Hospital
City
Siaya
Country
Kenya
Facility Name
Zomba Central Hospital
City
Zomba
Country
Malawi
Facility Name
Teule Hospital
City
Muheza
State/Province
Tanga
Country
Tanzania
Facility Name
Bugando Medical Centre
City
Mwanza
ZIP/Postal Code
1903
Country
Tanzania
Facility Name
Nyamagana District Hospital, c/o National Institute for Medical Research, Mwanza Centre
City
Mwanza
Country
Tanzania
Facility Name
Nyamagana District Hospital
City
Mwanza
Country
Tanzania
Facility Name
Mulago Hospital Complex
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Citations:
PubMed Identifier
29566732
Citation
Mtove G, Kimani J, Kisinza W, Makenga G, Mangesho P, Duparc S, Nakalembe M, Phiri KS, Orrico R, Rojo R, Vandenbroucke P. Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings. Trials. 2018 Mar 22;19(1):190. doi: 10.1186/s13063-018-2563-1.
Results Reference
derived
PubMed Identifier
27326859
Citation
Kimani J, Phiri K, Kamiza S, Duparc S, Ayoub A, Rojo R, Robbins J, Orrico R, Vandenbroucke P. Efficacy and Safety of Azithromycin-Chloroquine versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment of Plasmodium falciparum Malaria Infection in Pregnant Women in Africa: An Open-Label, Randomized Trial. PLoS One. 2016 Jun 21;11(6):e0157045. doi: 10.1371/journal.pone.0157045. eCollection 2016.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661158&StudyName=Evaluate%20Azithromycin%20Plus%20Chloroquine%20And%20Sulfadoxine%20Plus%20Pyrimethamine%20Combinations%20For%20Intermittent%20Preventive%20Treatment%20Of%20Falciparum%20Malar
Description
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Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
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