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Completed

NCT Number: NCT01019408

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

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.

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Key information

Age range

6 month–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Adezai Basic Health Unit, Adezai, Khyber Pakhtunkhwa, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chloroquine

Drug

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

Other names: CQ

Primary outcomes

  1. therapeutic and parasitological cure with no recrudescence

    Time frame: 60 days

Secondary outcomes

  1. parasite clearance time

    Time frame: 28 days

  2. fever clearance time

    Time frame: 28 days

  3. gametocytaemia

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • European Union
  • United Nations High Commissioner for Refugees
  • World Health Organization

Registry information

Official study title

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

Acronym: ECQNWFP

Important dates

Study start
1993
Primary completion
1995
Study completion
1995
First posted
Nov 25, 2009
Registry last updated
Nov 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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