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

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 4

Conditions: Malaria, Falciparum

Treatments: Drug: Chloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT01019408

NH-HNI01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 6 months to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

163 participants in 2 patient groups

CQ25

Active Comparator group

Description:

Falciparum positive patients receiving standard 3-day treatment course of CQ 25mg/kg.

Treatment:

Drug: Chloroquine

CQ40

Active Comparator group

Description:

Falciparum positive patients receiving a 5-day treatment course of CQ 40 mg/kg.

Treatment:

Drug: Chloroquine