Efficacy of Supervised and Unsupervised Chloroquine-Primaquine Treatment for Uncomplicated Plasmodium Vivax Malaria in Jimma Town, Southwest Ethiopia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Jimma University
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of Chloroquine (CQ) and Primaquine (PQ) against P.vivax infections in Ethiopia by recording recrudescent rates .
Study Overview
Brief Summary
The study was designed to evaluate the current efficacy of this combination therapy against P. vivax, given the possibility of misuse or inadequate adherence to the regimen due to its lengthy treatment duration, in one of a vivax-endemic area in southwest Ethiopia. A 42-day in vivo drug efficacy study was carried out as an open, two arm clinical trial involving 192 patients with uncomplicated P. vivax mono infection. Participants were allocated into two groups: supervised (n = 96) and unsupervised (n = 96). Both groups received CQ, 25 mg/kg over 3 days) and PQ, 0.25 mg/kg/day for 14 days). In the supervised group, treatment was administered under direct monitoring by healthcare providers and follow up was scheduled according to the World Health Organization (WHO) recommended drug efficacy testing protocol. Whereas patients in the unsupervised group were instructed to take their medication at home without direct monitoring and were advised to adhere to the treatment regimen. Their medication adherence and malaria episodes were monitored through scheduled phone follow ups.
Detailed Description
The study area The study was conducted at a health center in Jimma Town, Oromia Regional State, South-west Ethiopia. Jimma lies 352 km southwest of Addis Ababa, the capital city of Ethiopia. In this region, malaria transmission is seasonal, peaking during and after the rainy season, with P. falciparum and P. vivax co-endemic.
Study Participants and Eligibility Patients of all ages presenting with uncomplicated P. vivax malaria who fulfilled the inclusion criteria were recruited following the WHO protocol for antimalarial efficacy testing.
Sample Size Sample size was calculated assuming a 5% treatment failure rate for CQ plus PQ, with ±5% precision at 95% confidence, as per the standard of WHO anti-malarial efficacy testing guideline. After adjusting for 20% loss to follow-up, 96 participants were required per arm, yielding a total of 19.
Study Design An open-label, two-arm clinical trial was conducted. The patients' recruitment to the study was started on 01 December, 2024 and ended on November 30, 2025. Hence, the symptomatic vivax malaria patients were enrolled and randomly assigned to one of two treatment groups: supervised and unsupervised.
The supervised group received CQ (250 mg, batch no. 33342, Addis Pharmaceutical Factory PLC) and PQ (7.5 mg, batch no. 110701, Remedica Ltd., Cyprus) under direct observation, following national guidelines (CQ 25 mg/kg over 3 days; PQ 0.25 mg/kg daily for 14 days). Patients were monitored for 30 minutes post-dose; those vomiting once were re-treated, while those vomiting twice were excluded from the study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible patients were those Microscopy-confirmed mono-infection,
- •Axillary temperature ≥37.5 °C or fever history within 48 hours,
- •Parasite density >250 parasites/µl,
- •Ability to comply with follow-up,
- •Absence of severe malaria or danger signs,
- •Nnot pregnant or lactating,
- •No contraindication to CQ/PQ,
- •No recent antimalarial use, and
- •Provision of informed consent.
Exclusion Criteria
- •Patients didn't fulfilled the inclusion criteria (p.f infection, prior medication, chronic infections,allegy to the CQ-PQ and others)
Outcomes
Primary Outcomes
To assess the efficacy of Chloroquine (CQ) and Primaquine (PQ) against P.vivax infections in Ethiopia by recording recrudescent rates .
Time Frame: 42 days
This study assesses the efficacy of Chloroquine (CQ) and Primaquine (PQ) by recording recrudescent rates with supervised and without supervision groups
To assess the efficacy of Chloroquine (CQ) and Primaquine (PQ) against P.vivax infections in Ethiopia by recording parasitic clearance (adequate clinical and parasitological responses)
Time Frame: 42 days
This study assesses the efficacy of Chloroquine (CQ) and Primaquine (PQ) by recording parasitic clearance (adequate clinical and parasitological responses) in uncomplicated P.vivax patients who are given a standard dose of Chloroquine and primaquine treatment in supervised and without supervision groups
Secondary Outcomes
- the adherence rate of vivax malaria patients treated with CQ and PQ.(14 days)
Investigators
Tsige Ketema
Professor
Jimma University