Intermittent Preventive Therapy Post-Discharge: an innovative approach in the prevention of rebound severe malaria anaemia and mortality in young childre
- Conditions
- Severe malarial anaemiaInfections and InfestationsMalaria, anaemia
- Registration Number
- ISRCTN89727873
- Lead Sponsor
- iverpool School of Tropical Medicine (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1650
1. Haemoglobin <5.0 g/dl or packed cell volume (PCV) <15% on admission to the hospital
2. Plasmodium falciparum malaria (any documented parasitaemia) at the time of admission to the hospital or within 24 hours prior to admission
3. Aged between 4 months (inclusive) and 59 months (inclusive) at the time of randomization
4. Bodyweight >5 kg at the time of randomization
5. Subject completed blood transfusion(s) in accordance with routine hospital practice
6. Subject completed intravenous (IV) quinine in accordance with routine hospital practice
7. Able to feed (for breastfed children) or eat (for older children)
8. Able to sit unaided
9. Provision of informed consent by parent or guardian
1. Recognised, specific other cause of severe anaemia at the time of admission to the hospital (e.g. trauma, haematological malignancy, known bleeding disorder, known sickle cell disease)
2. Previous enrolment in the present study
3. Severe anaemia (haemoglobin <5.0 g/dl ) at the time of randomization
4. Known hypersensitivity to any of the study drugs
5. Documented intake of Coartem® (=4 doses) or SP within 1 week prior to admission
6. Child resides outside of catchment area during the course of the study (6 months)
7. Known need at the time of randomization for concomitant prohibited medication during the 2 months randomized treatment period
8. Ongoing participation into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study (6 months)
9. Known need, or scheduled surgery during the course of the study (6 months)
10. Suspected non-compliance with the follow-up schedule
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current information as of 22/04/2010:<br>The incidence of rebound severe anaemia (Hb less than 5 g/L), severe malaria (hospital admissions requiring quinine) or death (a composite endpoint) between 1 and 6 months after enrolment.<br><br>Initial information at time of registration:<br>Mean haemoglobin at three months
- Secondary Outcome Measures
Name Time Method Current information as of 22/04/2010:<br>1. The incidence of sick-child's clinic visits due to clinical malaria by 3 and 6 months<br>2. The incidence of all-cause sick-child's clinic visits by 3 and 6 months<br>3. The incidence of all cause re-hospitalisation between 1 - 3 and 1 - 6 months after enrolment<br>4. The incidence of the three individual components of the composite endpoint (severe anaemia, severe malaria, death) between 1 - 3 and 1 - 6 months after enrolment <br>5. Mean haemoglobin at 6 months<br>6. Incidence of adverse events by 3 and 6 months <br>7. Mean corrected heart rate (QTc) prolongation by 3 days <br><br>Initial information at time of registration:<br>1. The incidence of sick-child's clinic visits due to clinical malaria by 3 and 6 months<br>2. The incidence of rebound severe anaemia (Hb <5 g/l)<br>3. The incidence of death by 3 and 6 months<br>4. Mean haemoglobin at 6 months<br>5. Incidence of adverse events by 3 and 6 months <br>6. Mean corrected heart rate (QTc) prolongation by 3 days