Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan (ECQNWFP)
This study has been completed.
Sponsor:
London School of Hygiene and Tropical Medicine
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
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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
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 (Child, Adult) |
| 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
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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
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
| 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 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 |
ClinicalTrials.gov processed this record on September 27, 2016