Malaria (P. falciparum and P. vivax) Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
P. falciparum clinical trial:
All patients aged between 6 months and 15 years were eligible to be enrolled and were screened for malaria at the primary health centres in the sentinel s
Sponsors
Ministry of Health (Madagascar)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: P. falciparum trial: 1. Both males and females, aged between six months and 15 years 2. Monoinfection with P. falciparum at a parasitaemia between 1,000 and 200,000/µl 3. Axillary temperature greater than or equal to 37.5°C 4. Body weight greater than 5 kg 5. Absence of severe malnutrition (defined as a child whose weight-for-height is below 3 standard deviations of less than 70% of the median of World Health Organization [WHO] reference values, or who has symmetrical oedema involving at least the feet) 6. Absence of febrile conditions caused by diseases other than malaria 7. Absence of 'danger signs' (inability to stand, breastfeeding or drink; recent convulsions; lethargy or persistent vomiting) and of severe and complicated malaria 8. Haemoglobin (Hb) greater than or equal to 5 g/dl 9. Informed written consent of parents/guardians 10. Ability to attend stipulated follow-up visits 11. Absence of history of hypersensitivity reactions to any of the drugs being evaluated P. vivax trial: 1. Both males and females, aged greater than 6 months 2. Monoinfection with P. vvax at a parasitaemia above 250/µl 3. History of fever during 48 hours prior to time of recruitment 4. Ability and willingness to participate based on information given to parent or guardian and access to health facility 5. Informed consent
Exclusion criteria
Exclusion criteria: P. falciparum trial: 1. Aged less than 6 or greater than 16 years 2. Severe malnutrition (defined as a child whose weight-for-height is below 3 standard deviations of less than 70% of the median of WHO reference values, or who has symmetrical oedema involving at least the feet) 3. No slide confirmed infection with P. falciparum or a mixed infection that includes a non P. falciparum species 4. Initial parasite density less than 1,000 or greater than 200,000 asexual parasites per microlitre 5. Presence of general danger signs among children less than 5 years (inability to stand, breastfeeding or drink; recent convulsions; lethargy or persistent vomiting) and of severe and complicated malaria 6. Measured axillary temperature less than 37.5 °C 7. Inability to attend stipulated follow-up visits 8. Unwilling to provide informed consent provided by parent/guardian 9. History of hypersensitivity reactions to any of the drugs being evaluated P. vivax trial 1. Presence of clinical condition requiring hospitalisation 2. Presence of severe malnutrition 3. Pregnancy 4. Significant concomitant febrile illness which would interfere with follow-up 5. Chronic infectious diseases other than malaria (e.g., tuberculosis) 6. Known allergy and/or intolerance to drug(s) being tested
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| P. falciparum: Treatment outcomes were assessed according to WHO 2003 guidelines as Early Treatment Failure (ETF; danger signs or complicated malaria or failure to adequately respond to therapy on days 0 - 3), Late Clinical Failure (LCF; danger signs or complicated malaria or fever and parasitaemia on days 4 - 28 without previously meeting criteria for ETF), Late Parasitological Failure (LPF; asymptomatic parasitaemia on days 4 - 28 without previously meeting criteria for ETF or LCF), and Adequate Clinical and Parasitological Response (ACPR; absence of parasitaemia on day 28 without previously meeting criteria for ETF, LCF, or LPF). Overall Treatment failure (OFT) was considered as the sum of the ETP, LCT and LPF. Patients classified as having suffered treatment failure were treated with quinine (10 mg/kg three times daily for seven days); however, their response to repeat therapy was not assessed. P. vivax: Treatment outcomes were assessed according to WHO 2001 guidelines as "treatment failure" (TF; clinical deterioration due to P. vivax illness requiring hospitalisation, with parasitaemia and an axillary temperature of greater than or equal to 37.5°C any time between days 3 and 28, or parasitaemia on any day between days 7 and 28, regardless of clinical condition) or "adequate clinical and parasitological response" (ACPR; absence of parasitaemia on day 28 without the criteria for TF having been met previously). Patients with TF were treated with artesunate (4 mg/kg on days 0, 1, and 2) plus amodiaquine (10 mg/kg on days 0, 1, and 2), but their response to rescue therapy was not assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Madagascar
Outcome results
None listed