Back to resultsExtended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan (ECQNWFP)
Primary Purpose
Malaria, Falciparum
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Chloroquine
Sponsored by
About this trial
This is an interventional treatment trial for Malaria, Falciparum focused on measuring Clinical Trial, Chloroquine, Refugees, Afghanistan, Pakistan
Eligibility 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
Sites / Locations
- Adezai Basic Health Unit
- Baghicha Basic Health Unit
- Kagan Basic Health Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CQ25
CQ40
Arm Description
Falciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg.
Falciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg.
Outcomes
Primary Outcome Measures
therapeutic and parasitological cure with no recrudescence
Secondary Outcome Measures
parasite clearance time
fever clearance time
gametocytaemia
Full Information
NCT ID
NCT01019408
First Posted
November 23, 2009
Last Updated
November 23, 2009
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
European Union, United Nations High Commissioner for Refugees, World Health Organization
1. Study Identification
Unique Protocol Identification Number
NCT01019408
Brief Title
Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan
Acronym
ECQNWFP
Official Title
Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 1993 (undefined)
Primary Completion Date
January 1995 (Actual)
Study Completion Date
January 1995 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
European Union, United Nations High Commissioner for Refugees, World Health Organization
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum
Keywords
Clinical Trial, Chloroquine, Refugees, Afghanistan, Pakistan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CQ25
Arm Type
Active Comparator
Arm Description
Falciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg.
Arm Title
CQ40
Arm Type
Active Comparator
Arm Description
Falciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg.
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Other Intervention Name(s)
CQ
Intervention Description
Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan
Primary Outcome Measure Information:
Title
therapeutic and parasitological cure with no recrudescence
Time Frame
60 days
Secondary Outcome Measure Information:
Title
parasite clearance time
Time Frame
28 days
Title
fever clearance time
Time Frame
28 days
Title
gametocytaemia
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Rowland, PhD
Organizational Affiliation
LSHTM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adezai Basic Health Unit
City
Adezai
State/Province
Nwfp
Country
Pakistan
Facility Name
Baghicha Basic Health Unit
City
Baghicha
State/Province
Nwfp
Country
Pakistan
Facility Name
Kagan Basic Health Unit
City
Kagan
State/Province
Nwfp
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan
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