Intermittent Preventive Treatment for malaria in patient with Sickle Cell Disease

Not Applicable

Completed

• Conditions: Sickle cell anaemia and malaria prevention; Infections and Infestations; Plasmodium falciparum malaria

• Registration Number: ISRCTN46158146
• Lead Sponsor: Wellcome Trust (UK)

Brief Summary

2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25701866

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-14
• Study Completion: 2012-11-30
• Last Update Posted: 8 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Age 6months or older and >=5kg
2. Sickle cell clinic attendant
3. Both males and females
4. Agree to abide by the study protocol
5. Give informed consent and assent
6. Not acutely sick at the time of recruitment
7. Not having additional chronic disease
8. Haemoglobin (Hb) genotype of SS and SC confirmed by electrophoresis

Exclusion Criteria

1. Known allergy to any of the antimalarial drugs use in the trial
2. Severe illnesses requiring urgent admission
3. Treatment with sulfadoxine-pyrimethamine or mefloquine in the previous 2 weeks
4. Patients on cotrimoxazole prophylaxis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Incidence of adverse events [ Time Frame: 12 months ]<br> 2. Adherence to the recommended regimen [ Time Frame: 12 months ]<br> 3. The co-primary endpoints of the trial will be :<br> 3.1.The occurrence of any solicited adverse event<br> 3.2. The occurrence of vomiting<br> 3.3. The most commonly reported adverse event after IPT treatments and<br> 3.4. Adherence to the regimen ie the number of doses or complete courses of medication received by children in each group as a proportion of the number of doses/complete courses that should have been received<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Mean haemoglobin concentration 12 months after enrolment<br> 2. Occurrence of other common adverse events such as diarrhoea, skin rash, itching or nausea<br> 3. Number of hospital admissions during the surveillance period<br> 4. Number of blood transfusions received<br> 5. Number of cases of severe malaria during the surveillance period<br> 6. Number of out patient department (OPD) attendances with clinical malaria that meet the case definitions during the surveillance period (malaria episodes over time)<br> 7. Number of patients experiencing bone pain, haemolytic, and aplastic crises<br>