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

Phase 4

Completed

• Conditions: Malaria, Falciparum
• Interventions: Drug: Chloroquine

• Registration Number: NCT01019408
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 1993-11
• Primary Completion: 1995-01
• Study Completion: 1995-01
• Status Verified: 2009-11
• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Last Update Submitted: 2009-11-23
• Study First Posted: 2009-11-25
• Last Update Posted: 2009-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CQ25	Chloroquine	Falciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg.
CQ40	Chloroquine	Falciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg.

Primary Outcome Measures

Name	Time	Method
therapeutic and parasitological cure with no recrudescence	60 days

Secondary Outcome Measures

Name	Time	Method
parasite clearance time	28 days
fever clearance time	28 days
gametocytaemia	28 days

Trial Locations

Locations (3)

Adezai Basic Health Unit; 🇵🇰 Adezai, Nwfp, Pakistan

Baghicha Basic Health Unit; 🇵🇰 Baghicha, Nwfp, Pakistan

Kagan Basic Health Unit; 🇵🇰 Kagan, Nwfp, Pakistan