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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. parasite clearance time [ Time Frame: 28 days ]
2. fever clearance time [ Time Frame: 28 days ]
3. gametocytaemia [ Time Frame: 28 days ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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