To compare the response of children with sickle cell disease (SCD) and malaria to artemisinin combination therapy (ACT) antimalarials and the response of children without SCD treated with ACT for malaria

Artesunate-amodiaquine versus artemether-lumefantrine for uncomplicated malaria treatment in children with or without sickle cell disease: a randomized efficacy and safety trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96891086

Enrollment

120

Registered

2013-10-02

Start date

2011-01-04

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle cell disease/malaria Infections and Infestations Plasmodium falciparum malaria

Interventions

1. Artesunate-amodiaquine (Coarsucam®, Sanofi Aventis, France) - 25/50/100mg artesunate and 67.5/135/270mg amodiaquine, single daily dose, administered for three days according to body weight: 4.5-9k

9-18kg (50mg/135mg), 1 tablet/dose

18-36kg (100mg/270mg), 1 tablet/dose

36kg and over (100mg/270mg), 2 tablets/dose 2. Artemether-lumefantrine (Coartem®, Novartis Pharma AG, Basel, Switzerland) - 20mg artemether and 120mg lumefantrine administered at 0 and 8 hours on the

15-24kg, 2 tablets/dose

25-34kg, 3 tablets/dose

35kg and over, 4 tablets/dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children with SCD 2. Aged 6 months to 12 years 3. With acute P. falciparum malaria of parasite density < 200,000/µl 4. Consent obtained and willingness by parent or guardian to comply with the follow-up schedule

Exclusion criteria

Exclusion criteria: 1. Symptoms or signs of severe malaria requiring parenteral treatment 2. Weight less than 5 kg 3. Presence of danger signs of malaria 4. Known intolerance or allergy to study medications 5. Reported treatment with any of the study drugs one month preceding enrolment 6. Blood transfusion preceding 3 months before enrolment

Design outcomes

Primary

Measure	Time frame
1. Parasite clearance rates in the initial 48 hours of treatment: survival analysis 2. Parasite reduction ratio on days 1, 2, and 3: the ratio of the parasite count before treatment to the parasite count on days 1, 2, and 3	—

Secondary

Measure	Time frame
1. Cure rates as determined by PCR-corrected adequate clinical and parasitological response (ACPR): the proportion of patients with ACPR on days 28 and 42 2. Parasitological response on days 28 and 42: any recurrence of parasitaemia after initial clearance till day 28 or 42 3. Changes in haematological profiles during the follow-up period: changes from baseline (day 0) in the following parameters: haemoglobin (Hb), total white blood cell count (WBC), absolute neutrophil count (ANC) and platelet counts (PLT) on days 3, 7, 28, and 42 4. Incidence of adverse events: incidence of new or treatment-emergent adverse events on days 3, 7, 28 and 42	—

Measure

Time frame

1. Cure rates as determined by PCR-corrected adequate clinical and parasitological response (ACPR): the proportion of patients with ACPR on days 28 and 42 2. Parasitological response on days 28 and 42: any recurrence of parasitaemia after initial clearance till day 28 or 42 3. Changes in haematological profiles during the follow-up period: changes from baseline (day 0) in the following parameters: haemoglobin (Hb), total white blood cell count (WBC), absolute neutrophil count (ANC) and platelet counts (PLT) on days 3, 7, 28, and 42 4. Incidence of adverse events: incidence of new or treatment-emergent adverse events on days 3, 7, 28 and 42

—

Countries

Ghana

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026