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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
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
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
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013