Malaria
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (a) Adults and children aged one year and above or weight =10kg (b) Plasmodium parasite density in the range of 1000 asexual parasites per µl and above (c) Presence of fever or axillary temperature = 37.50 c ,or positive history of fever in the preceding 24hrs (d) Normal glucose-6-phosphate dehydrogenase (G6PD) enzyme levels based on a qualitative test (e) Haemoglobin level of 8g/dL and above (f) Residence in study area and or ability to come for the stipulated follow - up visits (g) Ability to take oral medications (h) Informed consent of participant or parent/guardian of participant
Exclusion criteria
Exclusion criteria: a) General danger signs or symptoms and signs of severe malaria (b) Febrile conditions caused by diseases other than malaria; will not respond to anti-malaria (c) Allergy to any of the drug components, or had used any of the component drugs within 28 days of enrollment, to avoid complications to therapy and masking effects of previous drug use. (d) Serious concomitant medical illness; or any medical illness not compatible with the study objectives; epilepsy or affective disorders may not understand trial protocol and give informed consent (e) Pregnancy detected clinically or by urine bHCG or lactating mother, drug safety in pregnancy and breastfeeding not ascertained (f) Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure was the effect of the standard single dose of Primaquine in addition to the completed 3-day treatment with DHP on gametocyte carriage. This was done by comparing the overall risk of gametocyte carriages on day 7 and then weekly till day 28, to measure the combined effect on gametocyte development and clearance (primary endpoint). | — |
Secondary
| Measure | Time frame |
|---|---|
| The impact of PQ on gametocytes was assessed using the following secondary endpoints: (1) The gametocyte clearance rates by day 28 in patients with gametocytes on day 3. (2) The incidence of gametocyte development by day 28 in patients who were gametocyte-free on day 3. (3) Gametocyte densities between days 3 and 28 inclusive. | — |
Countries
Nigeria
Contacts
Consultant Family Physician Jos University Teaching Hospital