Intermittent Preventive Treatment for Malaria in Patient With Sickle Cell Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-04-30

Brief Summary

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Malaria prophylaxis is recommended for sickle cell disease patients. In Nigeria, daily proguanil or weekly pyrimethamine are the most commonly prescribed regimens, but the current policy is not effective due to poor compliance and drug resistance. Intermittent treatment with a long acting drug regimen administered under supervision at clinic visits may be more effective. The aim of this trial 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 the daily proguanil. Two hundred and seventy patients with sickle cell disease attending the paediatric sickle cell disease clinic in Ilorin hospital who meet the eligibility criteria and have parental consent, will be randomized to one of three prophylactic regimens: daily proguanil, bimonthly sulfadoxine-pyrimethamine plus amodiaquine, or bimonthly mefloquine plus artesunate. Patients will be asked to return to clinic every two months and whenever they are sick. At enrollment, the study paediatrician will conduct a physical examination of the child, and collect a venous blood sample for a complete blood cell count and biochemical screen, determination of G6PD genotype, preparation of blood smears for malaria microscopy and a blood spot for determination of molecular markers of resistance. Four days after each clinic visit, patients will be interviewed (by phone and, for a subset, at home or in the clinic) to ask about compliance and adverse events. Participants will be followed for one year. The parents or carer will be encouraged to bring their child to the Outpatient Department clinic if the child becomes unwell. The primary outcome of the trial is tolerability, secondary outcomes are adherence to the regimen, and incidence of malaria and the number of hospitalizations over 12 months. If the bimonthly regimens are well tolerated and the preliminary data from this study are promising, a larger multicentre trial will be required to determine efficacy.

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Detailed Description

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Conditions

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Malaria Sickle Cell Crisis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Daily proguanil

Standard policy of a supply of proguanil tablets to be taken daily

Group Type ACTIVE_COMPARATOR

Proguanil

Intervention Type DRUG

Proguanil tablets, 1.5mg/kg/day

IPT with MQ+AS bimonthly

Intermittent Preventive Treatment (IPT) consisting of a bimonthly course of treatment with mefloquine-artesunate (MQ+AS)

Group Type EXPERIMENTAL

mefloquine plus artesunate

Intervention Type DRUG

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.

IPT with SP+AQ bimonthly

IPT with bimonthly course of treatment with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ)

Group Type EXPERIMENTAL

Sulfadoxine-pyrimethamine plus amodiaquine

Intervention Type DRUG

amodiaquine plus sulfadoxine-pyrimethamine 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).

Interventions

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Proguanil

Proguanil tablets, 1.5mg/kg/day

Intervention Type 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.

Intervention Type DRUG

Sulfadoxine-pyrimethamine plus amodiaquine

amodiaquine plus sulfadoxine-pyrimethamine 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

Eligibility Criteria

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Inclusion Criteria

* Age 6months or older and \>=5kg
* Sickle cell clinic attendant
* Both males and females
* Agree to abide by the study protocol
* Give informed consent and assent
* Not acutely sick at the time of recruitment
* Not having additional chronic disease
* Hb genotype of SS and SC confirmed by electrophoresis

Exclusion Criteria

* known allergy to any of the antimalarial drugs use in the trial,
* severe illnesses requiring urgent admission,
* treatment with sulfadoxine-pyrimethamine or mefloquine in the previous 2wks
* patients on cotrimoxazole prophylaxis

Minimum Eligible Age

6 Months

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes