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

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ClinicalTrials.gov Identifier: NCT01019408

Recruitment Status : Completed

First Posted : November 25, 2009

Last Update Posted : November 25, 2009

Sponsor:

Collaborators:

European Union

United Nations High Commissioner for Refugees

World Health Organization

Information provided by:

London School of Hygiene and Tropical Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Malaria, Falciparum	Drug: Chloroquine	Phase 4

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	163 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan
Study Start Date :	November 1993
Actual Primary Completion Date :	January 1995
Actual Study Completion Date :	January 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Drug Information available for: Chloroquine phosphate Chloroquine Chloroquine sulfate Chloroquine hydrochloride

Genetic and Rare Diseases Information Center resources: Malaria

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: CQ

Outcome Measures

Primary Outcome Measures :

therapeutic and parasitological cure with no recrudescence [ Time Frame: 60 days ]

Secondary Outcome Measures :

parasite clearance time [ Time Frame: 28 days ]
fever clearance time [ Time Frame: 28 days ]
gametocytaemia [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	6 Months to 60 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019408

Locations


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

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

European Union

United Nations High Commissioner for Refugees

World Health Organization

Investigators


Principal Investigator:	Mark Rowland, PhD	LSHTM

More Information


Responsible Party:	Mark Rowland, LSHTM
ClinicalTrials.gov Identifier:	NCT01019408 History of Changes
Other Study ID Numbers:	NH-HNI01
First Posted:	November 25, 2009 Key Record Dates
Last Update Posted:	November 25, 2009
Last Verified:	November 2009

Keywords provided by London School of Hygiene and Tropical Medicine:


Clinical Trial Chloroquine Refugees Afghanistan Pakistan

Additional relevant MeSH terms:


Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Chloroquine Chloroquine diphosphate Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antimalarials	Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics

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