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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17925871
Publication citations
-
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.