Condition category
Infections and Infestations
Date applied
31/10/2006
Date assigned
04/12/2006
Last edited
16/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christopher Drakeley

ORCID ID

Contact details

Joint Malaria Programme
Moshi
Box 2228
Tanzania
chris.drakeley@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The activity of sulphadoxine-pyrimethamine plus artesunate (SP+AS) and SP+AS followed by a single dose of primaquine (0.75 mg/kg ) against gametocytes in Tanzanian children with uncomplicated falciparum malaria

Acronym

GAM-PQ

Study hypothesis

Gametocytocidal drugs can play an important role in malaria control. The current study proposal is a pilot study to determine the efficacy of a gametocytocidal drug combination that consists of the extensively tested combination of Sulphadoxine-Pyrimethamine (SP) plus Artesunate (AS), followed by a single dose of Primaquine (PQ). This combination has previously been used and has been shown to be safe and efficient in clearing microscopic gametocytes. In this study we propose to confirm the safety in a Tanzanian population and to determine the added value of a single dose of PQ on the clearance of (sub-microscopic) gametocytes compared to SP and AS alone.

Hypothesis: Primaquine adds to the gametocyticidal effect of artesunate and clears sub-microscopic gametocytes.

Ethics approval

1. London School of Hygiene & Tropical Medicine - 24th July 2006 (ref: 4097)
2. National Insititue of Medical Research, Tanzania - 21st June 2006 (ref: NIMR/HQ/R.8A Vol.XIII/446)

Study design

Randomised single blind drug study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Uncomplicated febrile malaria

Intervention

Participants will be randomised to treatment with:
1. Sulfadoxine-pyrimethamine (SP) (500 mg S; 25 mg P/20 kg body weight, day zero) and artesunate (4 mg/kg, day zero, one, two) followed by a placebo (day two)
2. SP (500 mg S; 25 mg P/20 kg body weight, day zero) and AS (4 mg/kg, day zero, one, two) followed by primaquine (PQ) (0.75mg/kg, day two)

Intervention type

Drug

Phase

Not Applicable

Drug names

Sulphadoxine-pyrimethamine, artesunate and primaquine

Primary outcome measures

The following are assesed on days one, two, three, seven, 14, 28 and 42 after treatment:
1. Resolution of clinical symptoms
2. Haematological recovery
3. Presense of malaria parasites by microscopy and molecular technicques
4. Presence of sexual stage parasites by microscopy and molecular technicques

Secondary outcome measures

1. Haematological recovery in G6PD deficient and non deficient individuals
2. Selection of drug-resistant parasite strains after treatment

Overall trial start date

01/08/2006

Overall trial end date

13/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age more than three years
2. Residents of research area (5 km around the clinic)
3. Willingness to come for complete scheduled follow-up
4. Uncomplicated malaria with Plasmodium falciparum mono-infection
5. Parasitaemia of 500,000 to 900,000 parasites/ul
6. Temperature more than 37.5 and less than 39.5°C, or history of fever in the previous 24 hours
7. No history of adverse reactions to SP or PQ treatment
8. Understanding of the procedures of the study by parent or guardian and willing to participate by signing informed consent forms

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. General signs of severe malaria or haemoglobin count less than 8 g/dl
2. Presence of disease other than malaria causing febrile conditions
3. Unwilling to participate and sign informed consent forms
4. Eligibility for (or participation in) other malaria projects in the Korogwe area, notably the Intermittent Preventive Treatment of malaria in infants (IPTi) study

Recruitment start date

01/08/2006

Recruitment end date

13/10/2006

Locations

Countries of recruitment

Tanzania

Trial participating centre

Joint Malaria Programme
Moshi
Box 2228
Tanzania

Sponsor information

Organisation

The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO) (Netherlands)

Sponsor details

Laan van Nieuw Oost-Indië 300
P.O. Box 93138
Den Haag
2509 AC
Netherlands
+31 (0)70 344 06 40
nwo@nwo.nl

Sponsor type

Research organisation

Website

http://www.nwo.nl/nwohome.nsf/pages/NWOA_6UB9S8_Eng

Funders

Funder type

Research organisation

Funder name

The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO) (Netherlands) - Poverty Related Infection Oriented Research (PRIOR) (ref: WIZ93-465)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17925871

Publication citations

  1. Results

    Shekalaghe S, Drakeley C, Gosling R, Ndaro A, van Meegeren M, Enevold A, Alifrangis M, Mosha F, Sauerwein R, Bousema T, Primaquine clears submicroscopic Plasmodium falciparum gametocytes that persist after treatment with sulphadoxine-pyrimethamine and artesunate., PLoS ONE, 2007, 2, 10, e1023, doi: 10.1371/journal.pone.0001023.

Additional files

Editorial Notes