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

This study has been completed.

Sponsor:

Collaborators:

European Union

United Nations High Commissioner for Refugees

World Health Organization

Information provided by:

London School of Hygiene and Tropical Medicine

ClinicalTrials.gov Identifier:

NCT01019408

First received: November 23, 2009

Last updated: NA

Last verified: November 2009

History: No changes posted

Purpose

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	Intervention	Phase
Malaria, Falciparum	Drug: Chloroquine	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

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

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:

therapeutic and parasitological cure with no recrudescence [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

parasite clearance time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
fever clearance time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
gametocytaemia [ Time Frame: 28 days ] [ Designated as safety issue: No ]


Enrollment:	163
Study Start Date:	November 1993
Study Completion Date:	January 1995
Primary Completion Date:	January 1995 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	6 Months to 60 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	Mark Rowland, LSHTM
ClinicalTrials.gov Identifier:	NCT01019408 History of Changes
Other Study ID Numbers:	NH-HNI01
Study First Received:	November 23, 2009
Last Updated:	November 23, 2009
Health Authority:	Pakistan: Ministry of Health

Keywords provided by London School of Hygiene and Tropical Medicine:


Clinical Trial Chloroquine Refugees Afghanistan Pakistan

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015

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