Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax (CQ+PQ)
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| ClinicalTrials.gov Identifier: NCT06044805 |
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Recruitment Status :
Completed
First Posted : September 21, 2023
Last Update Posted : September 22, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Efficacy Malaria Chloroquine Vivax Malaria | Drug: Chloroquine Drug: Primaquine | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | December 19, 2022 |
| Actual Primary Completion Date : | March 13, 2023 |
| Actual Study Completion Date : | March 15, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Therapeutic Efficacy of Chloroquine Plus Primaquine
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. |
Drug: Chloroquine
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)
Other Names:
Drug: Primaquine Primaquine: 7.5 mg base tablet. Medication given as 0.25mg/kg daily for 14 days. |
- Early treatment failure [Time Frame: within the first 3 days] [ 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) [ Time Frame: 42 days ]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) [ Time Frame: 42 days ]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) [ Time Frame: 42 days ]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.
- The secondary outcome of this study is determining parasite clearance rate based on parasite clearance time. [ Time Frame: 42 days ]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. [ Time Frame: 42 days ]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. [ Time Frame: 42 days ]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. [ Time Frame: 42 days ]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. [ Time Frame: 42 days ]This study's secondary goal was evaluating the incidence of adverse events in 42 follow-up period.
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| Ages Eligible for Study: | 6 Months and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044805
| Ethiopia | |
| Shecha Health Center | |
| Arba Minch, South Ethiopia, Ethiopia | |
| Study Director: | Bockretsion Gidey | Ethiopian Public Health Institute |
Documents provided by Dinka Dugassa, Wollega University:
Other Publications:
| Responsible Party: | Dinka Dugassa, Principal Investigator, Wollega University |
| ClinicalTrials.gov Identifier: | NCT06044805 |
| Other Study ID Numbers: |
EPHI-IRB-294-2 |
| First Posted: | September 21, 2023 Key Record Dates |
| Last Update Posted: | September 22, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Therapeutic Efficacy Chloroquine Primaquine Ethiopia |
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Malaria Malaria, Vivax Protozoan Infections Parasitic Diseases Infections Mosquito-Borne Diseases Vector Borne Diseases Chloroquine Chloroquine diphosphate Primaquine Amebicides Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics |