NCT00158561

Brief Summary

To determine whether two cheap antifolates (chlorproguanil-dapsone and sulfadoxine-pyrimethamine) which work against falciparum malaria in this region are sufficiently effective against vivax malaria to be deployed in areas where diagnosis is poor and the burden of malaria is high, a randomised controlled trial of the three drugs is being undertaken comparing their efficacy in treating malaria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

September 9, 2005

Last Update Submit

January 11, 2017

Conditions

MalariaVivax Malaria

Keywords

vivaxtreatmentAsia

Outcome Measures

Primary Outcomes (1)

  • Day 14 slide clearance rate (complete clearance of parasites), assessed by microscopists who are blind to treatment allocation.

Secondary Outcomes (8)

  • Day 28 slide clearance rate defined as the number of treated patients with clearance of parasitaemia within 14 days of starting treatment, without subsequent recrudescence up to day 28.

  • Day 14 clinical failure rate (presence of symptoms of malaria in the presence of parasitaemia).

  • Day 28 clinical failure rate.

  • Adverse events.

  • Haemoglobin level increased by at least 1g/dl by day 14.

  • +3 more secondary outcomes

Interventions

sulfadoxine-pyrimethamine and chlorproguanil-dapsoneDRUG

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Presentation at BHU or clinic with probable clinical malaria.
  • Infection with P. vivax, confirmed by microscopy.
  • Age 3 years or older (no restriction on upper age limit).
  • Written or witnessed verbal consent obtained from the patient or the patients parent or guardian.
  • Married women of child bearing age confirmed to be non-pregnant at outset and willing to remain thus for the duration of the study.
  • Willingness to comply with the requirements of the protocol and particularly to provide venous and thumb prick blood samples.
  • Available for follow up for the duration of the study and not less than 6 months.
  • Willingness to report to the BHU or clinic if they feel unwell in the 6 months following completion (i.e. 7 months from enrolment date). NB these patients will only be those recruited up to 7 months before the end of the study period.
  • Availability of G6PD status by willingness to be tested at admission.

You may not qualify if:

  • General condition requiring hospital admission.
  • Evidence of any concomitant infection likely to mask treatment response at the time of presentation.
  • Presence of any other underlying disease that compromises the diagnosis and the evaluation of the response to the study medication.
  • History of allergy to sulphonamides, dapsone or chloroquine or hypersensitivity to biguanides (eg proguanil, chlorproguanil) sulphones (eg frusemide, thiazides, acetazolamide, and sulphonylureas) or any other tablet contents.
  • Known methaemoglobin reductase deficiency and haemoglobin M.
  • Treatment within the past twenty-eight days with sulfadoxine/pyrimethamine (Fansidar), sulfalene/pyrimethamine (Metakelfin), mefloquine-sulfadoxine-pyrimethamine (Fansimef); 21-days with mefloquine, or 7-days with amodiaquine, chloroquine, halofantrine, quinine (full course), primaquine, atovaquone - proguanil, artemisinin derivatives, co-artemether, trimethoprim, chloramphenicol, erythromycin, tetracycline or clindamycin.
  • Visible jaundice.
  • Use of an investigational drug within 30 days or 5 half-lives whichever is the longer.
  • Severe anaemia (Hb\<7 g/dl).
  • Other species of malaria seen.
  • Pregnancy, assessed by pregnancy test in all married women of child-bearing age (age over 14 and under 50).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthNet International

Peshawar, Pakistan

Location

Related Publications (1)

  • Leslie T, Mayan MI, Hasan MA, Safi MH, Klinkenberg E, Whitty CJ, Rowland M. Sulfadoxine-pyrimethamine, chlorproguanil-dapsone, or chloroquine for the treatment of Plasmodium vivax malaria in Afghanistan and Pakistan: a randomized controlled trial. JAMA. 2007 May 23;297(20):2201-9. doi: 10.1001/jama.297.20.2201.

    PMID: 17519409RESULT

MeSH Terms

Conditions

MalariaMalaria, Vivax

Interventions

fanasil, pyrimethamine drug combinationchloroguanil, dapsone drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Christopher Whitty, FRCP

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Mark Rowland, PhD

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

February 1, 2004

Study Completion

March 1, 2006

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

PA(1)