Intermittent Preventive Treatment for malaria in patient with Sickle Cell Disease
| ISRCTN | ISRCTN46158146 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46158146 |
| ClinicalTrials.gov number | NCT01319448 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/11/2011
- Registration date
- 14/11/2011
- Last edited
- 20/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Malaria is a serious tropical disease spread by mosquitoes that kills more than a million people each year, the majority in sub-Saharan Africa. Sickle cell anaemia is an inborn defect of the blood that occurs commonly in parts of the world such as sub-Saharan Africa where malaria is also very common. Sickle cell anaemia is associated with complications such as bone pain and anaemia (shortage of red blood cells). Malaria is an important trigger of these complications. Intermittent preventive treatment (IPT) involves administering antimalarial drugs at predetermined intervals. IPT using the drugs sulfadoxine-pyrimethamine has been found to reduce death and sickness due to malaria in infants, children and pregnant women. Proguanil is among the drugs presently being used for malaria prevention in patient with sickle cell anaemia. The aim of this study is to compare the tolerability and acceptability of supervised bimonthly treatment with either sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) or mefloquine plus artesunate (MQ+AS), with daily proguanil.
Who can participate?
Children aged 6 months or older with sickle cell anaemia.
What does the study involve?
Participants are randomly allocated into three groups, to receive either bimonthly treatment with SP+AQ, bimonthly treatment with MQ+AS, or daily proguanil. They take this for 12 months. The clinical and laboratory features of malaria are assessed and compared between the three groups.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
University of Ilorin Teaching Hospital (Nigeria).
When is the study starting and how long is it expected to run for?
September 2011 to November 2012.
Who is funding the study?
Wellcome Trust (UK).
Who is the main contact?
Dr Rasaq Olaosebikan
rolaosebikan@mrc.gm
Contact information
Scientific
Department of Paediatrics & Child Health
University of Ilorin Teaching Hospital
Oke Oyi
Ilorin
00234
Nigeria
| Phone | +234 (0)806 277 1228 |
|---|---|
| rolaosebikan@mrc.gm |
Study information
| Study design | Open-label randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised trial to compare the safety, tolerability and efficacy of bi-monthly intermittent preventive treatment with either artesunate plus mefloquine or amodiaquine plus sulfadoxine-pyrimethamine with the standard regimen of daily proguanil for the prevention of malaria and related complications in patients with sickle cell anaemia in Nigeria |
| Study acronym | SCD-IPT |
| Study objectives | Supervised bimonthly courses of treatment with mefloquine-artesunate (MQ+AS), or SP plus amodiaquine (SP+AQ), will be more effective in prevention of malaria and related complications in children with SCA compared to daily doses of proguanil and will be acceptable when taken on a long term basis. |
| Ethics approval(s) | 1. London School of Hygiene & Tropical Medicine Ethics Committee, 05/05/2011, ref: application No 5942 2. University of Ilorin Teaching Hospital Ethical Review Committee, 06/07/2011 |
| Health condition(s) or problem(s) studied | Sickle cell anaemia and malaria prevention |
| Intervention | Group 1 Daily proguanil: Active Comparator Standard policy of a supply of proguanil tablets to be taken daily Intervention: Drug: Proguanil Assigned intervention Proguanil tablets, 1.5mg/kg/day Group 2 IPT with MQ+AS bimonthly: Experimental Intermittent Preventive Treatment (IPT) consisting of a bimonthly course of treatment with mefloquine-artesunate (MQ+AS) Intervention: Drug: mefloquine plus artesunate Assigned intervention Drug: mefloquine plus artesunate This treatment is given once a day for 3 days. Patients weighing 5-8 kg receive one paediatric tablet per day, those weighing 9-17 kg two paediatric tablets, those weighing 18-29 kg one adult tablet and those weighing 30 kg and two adult tablets Group 3 IPT with SP+AQ bimonthly: Experimental IPT with bimonthly course of treatment with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) Assigned Intervention: Drug: Sulfadoxine-pyrimethamine plus amodiaquine supervised at each bimonthly clinic visit (amodiaquine 10mg/kg per day for three days and sulfadoxine-pyrimethamine (25/1.25 mg/kg) on the first day). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Proguanil, mefloquine, artesunate, sulfadoxine, pyrimethamine, amodiaquine |
| Primary outcome measure | 1. Incidence of adverse events [ Time Frame: 12 months ] 2. Adherence to the recommended regimen [ Time Frame: 12 months ] 3. The co-primary endpoints of the trial will be : 3.1.The occurrence of any solicited adverse event 3.2. The occurrence of vomiting 3.3. The most commonly reported adverse event after IPT treatments and 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 |
| Secondary outcome measures | 1. Mean haemoglobin concentration 12 months after enrolment 2. Occurrence of other common adverse events such as diarrhoea, skin rash, itching or nausea 3. Number of hospital admissions during the surveillance period 4. Number of blood transfusions received 5. Number of cases of severe malaria during the surveillance period 6. Number of out patient department (OPD) attendances with clinical malaria that meet the case definitions during the surveillance period (malaria episodes over time) 7. Number of patients experiencing bone pain, haemolytic, and aplastic crises |
| Overall study start date | 05/09/2011 |
| Completion date | 30/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Estimated enrollment: 270 participants |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/09/2011 |
| Date of final enrolment | 30/11/2012 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
00234
Nigeria
Sponsor information
Charity
215 Euston Road
London
NW1 2BE
United Kingdom
| Phone | +44(0)20 7811 8545 |
|---|---|
| E.Ralph@wellcome.ac.uk | |
| Website | http://wellcome.ac.uk |
"ROR" |
https://ror.org/029chgv08 |
Funders
Funder type
Charity
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/08/2015 | Yes | No |
Editorial Notes
20/03/2019: Publication reference added.
