Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan
ECQNWFP
Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan
1 other identifier
interventional
163
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 1993
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1993
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 1995
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 23, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedNovember 25, 2009
November 1, 2009
1.2 years
November 23, 2009
November 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
therapeutic and parasitological cure with no recrudescence
60 days
Secondary Outcomes (3)
parasite clearance time
28 days
fever clearance time
28 days
gametocytaemia
28 days
Study Arms (2)
CQ25
ACTIVE COMPARATORFalciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg.
CQ40
ACTIVE COMPARATORFalciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg.
Interventions
Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- European Unioncollaborator
- United Nations High Commissioner for Refugeescollaborator
- World Health Organizationcollaborator
Study Sites (3)
Adezai Basic Health Unit
Adezai, Khyber Pakhtunkhwa, Pakistan
Baghicha Basic Health Unit
Bāghīcha, Khyber Pakhtunkhwa, Pakistan
Kagan Basic Health Unit
Kagan, Khyber Pakhtunkhwa, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Rowland, PhD
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 23, 2009
First Posted
November 25, 2009
Study Start
November 1, 1993
Primary Completion
January 1, 1995
Study Completion
January 1, 1995
Last Updated
November 25, 2009
Record last verified: 2009-11