Radical cure of vivax malaria
| ISRCTN | ISRCTN14027467 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14027467 |
| Secondary identifying numbers | CP1 |
- Submission date
- 12/11/2011
- Registration date
- 16/11/2011
- Last edited
- 12/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
MORU
Faculty of Tropical Medicine
Mahidol University
Bangkok
10400
Thailand
| Phone | +66 (0)2 203 6301 |
|---|---|
| nickw@tropmedres.ac |
Study information
| Study design | Open-label randomised comparison |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Open label comparison of Chloroquine (CQ) alone versus CQ plus 5 days unobserved Primaquine or CQ plus 14 days unobserved primaquine |
| Study acronym | CqPq |
| Study objectives | 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(s) | 1. Calcultta School of Tropical Medicine, 2003 2. Faculty of Tropical Medicne, Mahidol University, 08/12/2005, ref: TM-IRB056/2005 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Chloroquine, primaquine |
| Primary outcome measure | Relapse rate |
| Secondary outcome measures | Adverse effects |
| Overall study start date | 01/04/2003 |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Age > 3 years 2. Fully informed consent to long follow-up 3. Acute uncomplicated vivax malaria 4. Not pregnant |
| Key exclusion criteria | 1. <3 years 2. Pregnancy 3. Severe disease |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- India
- Thailand
Study participating centre
10400
Thailand
Sponsor information
University/education
Faculty of Tropical Medicine
420/6 Rajvithi Rd
Bangkok
10400
Thailand
"ROR" |
https://ror.org/01znkr924 |
|---|
Funders
Funder type
Charity
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2012 | Yes | No |
Editorial Notes
12/05/2017: Plain English summary added.
