NCT01019408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 1993

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1993

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1995

Completed
14.9 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

1.2 years

First QC Date

November 23, 2009

Last Update Submit

November 23, 2009

Conditions

Keywords

Clinical TrialChloroquineRefugeesAfghanistanPakistan

Outcome Measures

Primary Outcomes (1)

  • therapeutic and parasitological cure with no recrudescence

    60 days

Secondary Outcomes (3)

  • parasite clearance time

    28 days

  • fever clearance time

    28 days

  • gametocytaemia

    28 days

Study Arms (2)

CQ25

ACTIVE COMPARATOR

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

Drug: Chloroquine

CQ40

ACTIVE COMPARATOR

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

Drug: Chloroquine

Interventions

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

Also known as: CQ
CQ25CQ40

Eligibility Criteria

Age6 Months - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Adezai Basic Health Unit

Adezai, Khyber Pakhtunkhwa, Pakistan

Location

Baghicha Basic Health Unit

Bāghīcha, Khyber Pakhtunkhwa, Pakistan

Location

Kagan Basic Health Unit

Kagan, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mark Rowland, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 25, 2009

Study Start

November 1, 1993

Primary Completion

January 1, 1995

Study Completion

January 1, 1995

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations