The GAMetocyticidal activity of sulphadoxine-pyremthamine plus artesunate followed by a single dose of PrimaQuine
| ISRCTN | ISRCTN61534963 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61534963 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/10/2006
- Registration date
- 04/12/2006
- Last edited
- 16/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Christopher Drakeley
Scientific
Scientific
Joint Malaria Programme
Moshi
Box 2228
Tanzania
| chris.drakeley@lshtm.ac.uk |
Study information
| Study design | Randomised single blind drug study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 |
| Study acronym | GAM-PQ |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/08/2006 |
| Completion date | 13/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 13/10/2006 |
Locations
Countries of recruitment
- Tanzania
Study participating centre
Joint Malaria Programme
Moshi
Box 2228
Tanzania
Box 2228
Tanzania
Sponsor information
The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO) (Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost-Indië 300
P.O. Box 93138
Den Haag
2509 AC
Netherlands
| Phone | +31 (0)70 344 06 40 |
|---|---|
| nwo@nwo.nl | |
| Website | http://www.nwo.nl/nwohome.nsf/pages/NWOA_6UB9S8_Eng |
"ROR" |
https://ror.org/04jsz6e67 |
Funders
Funder type
Research organisation
The Netherlands Foundation for the Advancement of Tropical Research (NWO-WOTRO) (Netherlands) - Poverty Related Infection Oriented Research (PRIOR) (ref: WIZ93-465)
No information available
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 | 10/10/2007 | Yes | No |
