The GAMetocyticidal activity of sulphadoxine-pyremthamine plus artesunate followed by a single dose of PrimaQuine

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61534963

Enrollment

100

Registered

2006-12-04

Start date

2006-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated febrile malaria Infections and Infestations Malaria

Interventions

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)

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

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

Primary

Measure	Time frame
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	—

Countries

Tanzania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026