Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan
Information source: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria, Falciparum
Intervention: Chloroquine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: London School of Hygiene and Tropical Medicine Official(s) and/or principal investigator(s):
Mark Rowland, PhD, Principal Investigator, Affiliation: LSHTM
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.
Clinical Details
Official title: Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: therapeutic and parasitological cure with no recrudescence
Secondary outcome: parasite clearance timefever clearance time gametocytaemia
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
Minimum age: 6 Months.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Adezai Basic Health Unit, Adezai, Nwfp, Pakistan
Baghicha Basic Health Unit, Baghicha, Nwfp, Pakistan
Kagan Basic Health Unit, Kagan, Nwfp, Pakistan
Additional Information
Starting date: November 1993
Last updated: November 23, 2009
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