Condition category
Infections and Infestations
Date applied
12/11/2011
Date assigned
16/11/2011
Last edited
12/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Malaria is a serious tropical disease spread by mosquitoes. It can be prevented and treated using antimalarial medication, but it often comes back again after treatment. These relapses can be prevented only by the drug primaquine, but there is uncertainty about how long primaquine should be given for. The aim of this study is to compare two widely recommended ways of giving primaquine, a short course and a long course, to see which is better at preventing relapse.

Who can participate?
Patients age over 3 with malaria

What does the study involve?
Participants are randomly allocated to one of three groups. The first group is treated with chloroquine only for 3 days. The second group is treated with chloroquine followed by primaquine for 5 days. The third group is treated with chloroquine followed by primaquine for 14 days. Malaria relapse rate and side effects are assessed in all three groups.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Mahidol University (Thailand)

When is the study starting and how long is it expected to run for?
April 2003 to September 2004

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Prof. Nicholas White
nickw@tropmedres.ac

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nicholas White

ORCID ID

Contact details

MORU
Faculty of Tropical Medicine
Mahidol University
Bangkok
10400
Thailand
+66 (0)2 203 6301
nickw@tropmedres.ac

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CP1

Study information

Scientific title

Open label comparison of Chloroquine (CQ) alone versus CQ plus 5 days unobserved Primaquine or CQ plus 14 days unobserved primaquine

Acronym

CqPq

Study hypothesis

Radical cure of vivax malaria requires 14 days primaquine. However, a 5-day regimen has been widely recommended. This trial compares the two radical regimens versus no primaquine.

Ethics approval

1. Calcultta School of Tropical Medicine, 2003
2. Faculty of Tropical Medicne, Mahidol University, 08/12/2005, ref: TM-IRB056/2005

Study design

Open-label randomised comparison

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Vivax malaria

Intervention

1. Chloroquine (25mg base/kg total) only ; 10mg/kg on day 1, 10mg/kg on day 2 then 5mg/kg on day 3
2. Chloroquine (25mg base/kg total as above) followed by primaquine 0.25mg base/kg/day for 5 days-total dose 1.25mg base/kg (75mg in an adult)
3. Chloroquine (25mg base/kg total) followed by primaquine 0.25mg base/kg/ day for 14 days -total dose 3.5mg base/kg (210mg in an adult)

Intervention type

Drug

Phase

Not Applicable

Drug names

Chloroquine, primaquine

Primary outcome measures

Relapse rate

Secondary outcome measures

Adverse effects

Overall trial start date

01/04/2003

Overall trial end date

01/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age > 3 years
2. Fully informed consent to long follow-up
3. Acute uncomplicated vivax malaria
4. Not pregnant

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. <3 years
2. Pregnancy
3. Severe disease

Recruitment start date

01/04/2003

Recruitment end date

01/09/2004

Locations

Countries of recruitment

India

Trial participating centre

Mahidol University
Bangkok
10400
Thailand

Sponsor information

Organisation

Mahidol University (Thailand)

Sponsor details

Faculty of Tropical Medicine
420/6 Rajvithi Rd
Bangkok
10400
Thailand

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK) (reference No. 066439/2/01/2)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22808048

Publication citations

  1. Results

    Kim JR, Nandy A, Maji AK, Addy M, Dondorp AM, Day NP, Pukrittayakamee S, White NJ, Imwong M, Genotyping of Plasmodium vivax reveals both short and long latency relapse patterns in Kolkata., PLoS ONE, 2012, 7, 7, e39645, doi: 10.1371/journal.pone.0039645.

Additional files

Editorial Notes

12/05/2017: Plain English summary added.