Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan

Study Overview
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Brief Summary
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The purpose of this study was to provide stronger evidence for extended-dose chloroquine treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP), Pakistan or justification for discontinuation of the policy.

Detailed Description
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To determine whether extended-dose chloroquine provided better cure rates and fewer recrudescences than standard chloroquine treatment among Afghan refugees, 163 falciparum patients from three Afghan refugee camps were recruited into 3-day (CQ 25mg/kg) or 5-day (CQ 40mg/kg) treatment arms and followed for up to 60 days.

Official Title
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Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan

Conditions
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Malaria, Falciparum

Intervention / Treatment
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* Drug: Chloroquine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: slide-confirmed infection with P. falciparum only initial parasite density of 1000-100,000 asexual parasites/μl absence of severe malnutrition ability to attend stipulated follow-up visits and easy access to facility informed consent provided by patient or parent/guardian absence of history of hypersensitivity reactions to CQ Exclusion Criteria: infants under six months old pregnancy or lactation underlying chronic severe illness patients with other febrile illnesses parasitaemia outside the range of 1000-100,000 asexual parasites/µl severe malaria

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CQ25<br>Falciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg. | Drug: Chloroquine<br>* Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan<br>* Other names: CQ;|
| Active Comparator: CQ40<br>Falciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg. | Drug: Chloroquine<br>* Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan<br>* Other names: CQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic and parasitological cure with no recrudescence |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parasite clearance time |  | 28 days | 
| fever clearance time |  | 28 days | 
| gametocytaemia |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Trial, Chloroquine, Refugees, Afghanistan, Pakistan