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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01019408
Other study ID # NH-HNI01
Secondary ID
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


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
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