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

NCT ID: NCT01019408

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-11-30

Study Completion Date

1995-01-31

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.

Conditions

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Malaria, Falciparum

Keywords

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Clinical Trial Chloroquine Refugees Afghanistan Pakistan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CQ25

Falciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg.

Group Type ACTIVE_COMPARATOR

Chloroquine

Intervention Type DRUG

Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan

CQ40

Falciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg.

Group Type ACTIVE_COMPARATOR

Chloroquine

Intervention Type DRUG

Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan

Interventions

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Chloroquine

Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan

Intervention Type DRUG

Other Intervention Names

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CQ

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
Minimum Eligible Age

6 Months

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Union

OTHER

Sponsor Role collaborator

United Nations High Commissioner for Refugees

OTHER

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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LSHTM

Principal Investigators

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Mark Rowland, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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Adezai Basic Health Unit

Adezai, Khyber Pakhtunkhwa, Pakistan

Site Status

Baghicha Basic Health Unit

Bāghīcha, Khyber Pakhtunkhwa, Pakistan

Site Status

Kagan Basic Health Unit

Kāgān Dheri, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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NH-HNI01

Identifier Type: -

Identifier Source: org_study_id