Back to resultsTherapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax (CQ+PQ)
Primary Purpose
Efficacy, Malaria, Chloroquine
Status
Completed
Phase
Phase 4
Locations
Ethiopia
Study Type
Interventional
Intervention
Chloroquine
Primaquine
Sponsored by
About this trial
This is an interventional treatment trial for Efficacy focused on measuring Therapeutic, Efficacy, Chloroquine, Primaquine, Ethiopia
Eligibility Criteria
Inclusion Criteria: Age > 6 months Slide confirmed infection with P. vivax with > 250 asexual forms/μl Lives within 5 km of the enrolling health facility Weight ≥ 5.0 kg Ability to swallow oral medication Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule Informed consent from patient or from a parent or guardian in the case of children Exclusion Criteria: Sever malaria with complication sign and symptoms Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean, symmetrical edema involving at least the feet, or mid-upper arm circumference <100 cm for children less than five years of age Mixed plasmodium infection Severe anemia, defined as hemoglobin (Hb) < 5 g/dl Presence of febrile conditions caused by diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) Serious or chronic medical condition (e.g. cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS) Positive pregnancy test or breastfeeding Unable or unwilling to take contraceptives for women of child-bearing age Children weighing less than 5 kilograms History of hypersensitivity reaction to any medication tested or used as an alternative treatment Participants with history of prolonged QT conditions Taking regular medication, which may interfere with antimalarial pharmacokinetics or efficacy
Sites / Locations
- Shecha Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapeutic Efficacy of Chloroquine Plus Primaquine
Arm Description
An invivo single arm trial. Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1(10mg/kg) and 2 (5mg/kg). Total dose, 25 mg base/kg. Primaquine - it was given once a day (0.25 mg/kg) for fourteen days, starting on day 0 of CQ treatment. Total dose, 3.5mg/kg. The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes.
Outcomes
Primary Outcome Measures
Early treatment failure [Time Frame: within the first 3 days]
Danger signs or severe malaria on day 1, day 2 or day 3 in the presence of parasitemia;Parasitemia on day 2 higher than on day 0, irrespective of axillary temperature;Parasitemia on day 3 with axillary temperature ≥37.5 ºC;Parasitemia on day 3 ≥25% of count on day 0.
Late Clinical Failure (LCF)
Danger signs or severe malaria in the presence of parasitemia on any day between day 4 and 42 in patients who did not previously meet any of the criteria of Early Treatment Failure; Presence of parasitemia on any day between 4 and day 42 with axillary temperature ≥37.5 °C (or history of fever) in patients who did not previously meet any of the criteria of Early Treatment Failure.
Late Parasitological Failure (LPF)
Presence of parasitemia on any day between day 7 and day 42 and axillary temperature <37.5 ºC in patients who did not previous meeting any of the criteria of Early Treatment Failure or Late Clinical Failure.
Adequate Clinical and Parasitological Response (ACPR)
Absence of parasitemia on day 42 irrespective of axillary temperature, in patients who did not previously meet any of the criteria of Early Treatment Failure, Late Clinical Failure, or Late Parasitological Failure.
Secondary Outcome Measures
The secondary outcome of this study is determining parasite clearance rate based on parasite clearance time.
This study's secondary goal was to calculate the parasite clearance rate based on parasite clearance time. Using hours, days, weeks, and months, parasite clearance time is calculated.
The secondary outcome of this study is determining gametocyte clearance rate based on gametocyte clearance time.
This study's secondary goal was to calculate the gametocyte clearance rate based on gametocyte clearance time. Using hours, days, weeks, and months, parasite clearance time is calculated.
The secondary outcome of this study is determining fever clearance rate based on fever clearance time.
Calculating the fever clearance rate based on fever clearance time was the secondary outcome of this clinical trial. Fever clearance time is calculated using hours, days, weeks, and months. Temperatures less than 37.5 degrees celsius (T 37.5oC) are deemed to be fever-free(fever cleared) while temperatures greater than or equal to 37.5 degrees celsius (T>37.5oC) are classified as having fever (fever not cleared).
The secondary outcome of this study is determining mean hemoglobin change overtime in the 42 days study period.
Calculating the mean hemoglobin change overtime in the 42 study period based on hemoglobin concentration at D0, D14, D28 and D42 was the secondary outcome of this clinical trial. Milligrammes per deciliter are used to measure the concentration of haemoglobin.
The secondary outcome of this study is evaluating the incidence of adverse events in 42 follow-up period.
This study's secondary goal was evaluating the incidence of adverse events in 42 follow-up period.
Full Information
NCT ID
NCT06044805
First Posted
July 6, 2023
Last Updated
September 19, 2023
Sponsor
Dinka Dugassa
Collaborators
Ethiopian Public Health Institute
1. Study Identification
Unique Protocol Identification Number
NCT06044805
Brief Title
Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax
Acronym
CQ+PQ
Official Title
Monitoring Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax Based on Clinical, Parasitologic and Hematologic Parameters in Shecha Health Center: Open Label Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dinka Dugassa
Collaborators
Ethiopian Public Health Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this open label clinical trial will be to assess the therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia.
The main question it aims to answer:- the current therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia based on clinical, parasitological and hematological parameter.
Participants will be patients aged >6 months with diagnosis of plasmodium vivax mono-infection and who fulfills the inclusion criteria.
This is a single arm open label invivo therapeutic efficacy study of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax. The final result will be compared with World Health Organization recommendation on antimalarial drug therapeutic efficacy.
Detailed Description
The goal of this open label clinical trial will be to assess the therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia. The main question it aims to answer:- the current therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia based on clinical, parasitological and hematological parameter.
Participants will be patients aged >6 months with diagnosis of plasmodium vivax mono-infection and who fulfills the inclusion criteria.
This is a single arm open label invivo therapeutic efficacy study of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax. The final result will be compared with World Health Organization recommendation on antimalarial drug therapeutic efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy, Malaria, Chloroquine, Vivax Malaria
Keywords
Therapeutic, Efficacy, Chloroquine, Primaquine, Ethiopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open label clinical trial study will be conducted in Shecha Health Center from December 2022 to March 2023. Participants will be selected and treated with a 25 mg/kg standard dose of chloroquine over three days and a 0.25 mg/kg standard dose of primaquine over fourteen days. Clinical, parasitologic, and hematologic parameters will be monitored for up to a 42-day follow-up period, which will be used to evaluate therapeutic efficacy of CQ+PQ. Thick and thin blood smears will be prepared and examined to determine parasite clearance, and clinical examination will be performed over 42 follow up periods. Haemoglobin level will be measured on days 0, 14, 28 and 42. WHO double-entry Excel sheet will be used for KaplanMeier survival analysis and SPSS version-26 software will be used to analyse the data. All comparisons will be performed at 95% confidence interval and a significance level of 0.05, Pvalue of <0.05 will be considered statistically significant
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic Efficacy of Chloroquine Plus Primaquine
Arm Type
Experimental
Arm Description
An invivo single arm trial. Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1(10mg/kg) and 2 (5mg/kg). Total dose, 25 mg base/kg.
Primaquine - it was given once a day (0.25 mg/kg) for fourteen days, starting on day 0 of CQ treatment. Total dose, 3.5mg/kg.
The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes.
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Other Intervention Name(s)
Chloroquine base, Chloroquine Phosphate
Intervention Description
Total of 25mg base per kg over 3 days (10 mg base/kg on Days 0 and 1, 5 mg base/kg on Day 2)
Intervention Type
Drug
Intervention Name(s)
Primaquine
Intervention Description
Primaquine: 7.5 mg base tablet. Medication given as 0.25mg/kg daily for 14 days.
Primary Outcome Measure Information:
Title
Early treatment failure [Time Frame: within the first 3 days]
Description
Danger signs or severe malaria on day 1, day 2 or day 3 in the presence of parasitemia;Parasitemia on day 2 higher than on day 0, irrespective of axillary temperature;Parasitemia on day 3 with axillary temperature ≥37.5 ºC;Parasitemia on day 3 ≥25% of count on day 0.
Time Frame
within the first 3 days
Title
Late Clinical Failure (LCF)
Description
Danger signs or severe malaria in the presence of parasitemia on any day between day 4 and 42 in patients who did not previously meet any of the criteria of Early Treatment Failure; Presence of parasitemia on any day between 4 and day 42 with axillary temperature ≥37.5 °C (or history of fever) in patients who did not previously meet any of the criteria of Early Treatment Failure.
Time Frame
42 days
Title
Late Parasitological Failure (LPF)
Description
Presence of parasitemia on any day between day 7 and day 42 and axillary temperature <37.5 ºC in patients who did not previous meeting any of the criteria of Early Treatment Failure or Late Clinical Failure.
Time Frame
42 days
Title
Adequate Clinical and Parasitological Response (ACPR)
Description
Absence of parasitemia on day 42 irrespective of axillary temperature, in patients who did not previously meet any of the criteria of Early Treatment Failure, Late Clinical Failure, or Late Parasitological Failure.
Time Frame
42 days
Secondary Outcome Measure Information:
Title
The secondary outcome of this study is determining parasite clearance rate based on parasite clearance time.
Description
This study's secondary goal was to calculate the parasite clearance rate based on parasite clearance time. Using hours, days, weeks, and months, parasite clearance time is calculated.
Time Frame
42 days
Title
The secondary outcome of this study is determining gametocyte clearance rate based on gametocyte clearance time.
Description
This study's secondary goal was to calculate the gametocyte clearance rate based on gametocyte clearance time. Using hours, days, weeks, and months, parasite clearance time is calculated.
Time Frame
42 days
Title
The secondary outcome of this study is determining fever clearance rate based on fever clearance time.
Description
Calculating the fever clearance rate based on fever clearance time was the secondary outcome of this clinical trial. Fever clearance time is calculated using hours, days, weeks, and months. Temperatures less than 37.5 degrees celsius (T 37.5oC) are deemed to be fever-free(fever cleared) while temperatures greater than or equal to 37.5 degrees celsius (T>37.5oC) are classified as having fever (fever not cleared).
Time Frame
42 days
Title
The secondary outcome of this study is determining mean hemoglobin change overtime in the 42 days study period.
Description
Calculating the mean hemoglobin change overtime in the 42 study period based on hemoglobin concentration at D0, D14, D28 and D42 was the secondary outcome of this clinical trial. Milligrammes per deciliter are used to measure the concentration of haemoglobin.
Time Frame
42 days
Title
The secondary outcome of this study is evaluating the incidence of adverse events in 42 follow-up period.
Description
This study's secondary goal was evaluating the incidence of adverse events in 42 follow-up period.
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 6 months
Slide confirmed infection with P. vivax with > 250 asexual forms/μl
Lives within 5 km of the enrolling health facility
Weight ≥ 5.0 kg
Ability to swallow oral medication
Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule
Informed consent from patient or from a parent or guardian in the case of children
Exclusion Criteria:
Sever malaria with complication sign and symptoms
Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean, symmetrical edema involving at least the feet, or mid-upper arm circumference <100 cm for children less than five years of age
Mixed plasmodium infection
Severe anemia, defined as hemoglobin (Hb) < 5 g/dl
Presence of febrile conditions caused by diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration)
Serious or chronic medical condition (e.g. cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
Positive pregnancy test or breastfeeding
Unable or unwilling to take contraceptives for women of child-bearing age
Children weighing less than 5 kilograms
History of hypersensitivity reaction to any medication tested or used as an alternative treatment
Participants with history of prolonged QT conditions
Taking regular medication, which may interfere with antimalarial pharmacokinetics or efficacy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bockretsion Gidey
Organizational Affiliation
Ethiopian Public Health Institute
Official's Role
Study Director
Facility Information:
Facility Name
Shecha Health Center
City
Arba Minch
State/Province
South Ethiopia
Country
Ethiopia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32110001
Citation
Fekadu G, Dugassa D, Negera GZ, Woyessa TB, Turi E, Tolossa T, Fetensa G, Assefa L, Getachew M, Shibiru T. Self-Medication Practices and Associated Factors Among Health-Care Professionals in Selected Hospitals of Western Ethiopia. Patient Prefer Adherence. 2020 Feb 20;14:353-361. doi: 10.2147/PPA.S244163. eCollection 2020.
Results Reference
background
PubMed Identifier
34336132
Citation
Fekadu G, Bekele F, Tolossa T, Fetensa G, Turi E, Getachew M, Abdisa E, Assefa L, Afeta M, Demisew W, Dugassa D, Diriba DC, Labata BG. Impact of COVID-19 pandemic on chronic diseases care follow-up and current perspectives in low resource settings: a narrative review. Int J Physiol Pathophysiol Pharmacol. 2021 Jun 15;13(3):86-93. eCollection 2021.
Results Reference
result
PubMed Identifier
33552517
Citation
Bekele F, Fekadu G, Bekele K, Dugassa D, Sori J. Drug-related problems among patients with infectious disease admitted to medical wards of Wollega University Referral Hospital: Prospective observational study. SAGE Open Med. 2021 Jan 22;9:2050312121989625. doi: 10.1177/2050312121989625. eCollection 2021.
Results Reference
result
PubMed Identifier
33299558
Citation
Fekadu G, Turi E, Kasu T, Bekele F, Chelkeba L, Tolossa T, Labata BG, Dugassa D, Fetensa G, Diriba DC. Impact of HIV status and predictors of successful treatment outcomes among tuberculosis patients: A six-year retrospective cohort study. Ann Med Surg (Lond). 2020 Nov 15;60:531-541. doi: 10.1016/j.amsu.2020.11.032. eCollection 2020 Dec.
Results Reference
result
Learn more about this trial
Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax
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