Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan

Malaria, Falciparum Clinical Trial

— ECQNWFP  

Official title:

Clinical Trial of Extended-dose Chloroquine Versus Standard Chloroquine Treatment for Resistant Falciparum Malaria Among Afghan Refugees in NWFP Pakistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019408
• Other study ID #: NH-HNI01
• Status: Completed
• Phase: Phase 4
• First received: November 23, 2009
• Last updated: November 23, 2009
• Start date: November 1993
• Est. completion date: January 1995

Study information

• Verified date: November 2009
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: January 1995
• Est. primary completion date: January 1995
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Chloroquine
Comparison of two different dosages of chloroquine for treatment of falciparum malaria in Afghan refugee camps in Northwest Frontier Province, Pakistan

Locations

Country	Name	City	State
Pakistan	Adezai Basic Health Unit	Adezai	Nwfp
Pakistan	Baghicha Basic Health Unit	Baghicha	Nwfp
Pakistan	Kagan Basic Health Unit	Kagan	Nwfp

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	European Union, United Nations High Commissioner for Refugees, World Health Organization

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	therapeutic and parasitological cure with no recrudescence		60 days	No
Secondary	parasite clearance time		28 days	No
Secondary	fever clearance time		28 days	No
Secondary	gametocytaemia		28 days	No