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

November 23, 2009 updated by: London School of Hygiene and Tropical Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

163

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Nwfp
      • Adezai, Nwfp, Pakistan
        • Adezai Basic Health Unit
      • Baghicha, Nwfp, Pakistan
        • Baghicha Basic Health Unit
      • Kagan, Nwfp, Pakistan
        • Kagan Basic Health Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
therapeutic and parasitological cure with no recrudescence
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
parasite clearance time
Time Frame: 28 days
28 days
fever clearance time
Time Frame: 28 days
28 days
gametocytaemia
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

World Health Organization
European Union
United Nations High Commissioner for Refugees

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1993

Primary Completion (Actual)

January 1, 1995

Study Completion (Actual)

January 1, 1995

Study Registration Dates

First Submitted

November 23, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 23, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NH-HNI01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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