Updating the efficacy study of artemether-lumefantrine for the treatment of uncomplicated P falciparum malaria in sentinel sites in the Comoros Islands.

Safety and efficacy, in terms of adequate clinical and parasitological response, of artemether lumefantrine for the treatment of children with uncomplicated P. falciparum malaria in Comoros Islands.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613000586718

Enrollment

560

Registered

2013-05-24

Start date

2013-06-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Therapeutic efficacy study of the fixed combination of artemether-lumefantrine (20 mg artemether/ 120 mg lumefantrine) administered orally twice a day for three consecutive days. The number of tablets per dosing will be based on body weight per standard of care. Patients will be seen daily for the first three days and then return to the health center weekly (day 7, 14, 21 and 28) for clinical and parasitological evaluation or any other day if symptoms re-occurred.

Interventions

Therapeutic efficacy study of the fixed combination of artemether-lumefantrine ( 20 mg artemether/ 120 mg lumefantrine) administered orally twice a day for three consecutive days. The number of tablets to be administered at each dosing day will be based on body weight as per standard of care. Patients will be seen daily for the first three days and then return to the health center weekly (day 7, 14, 21 and 28) for clinical and parasitological evaluation or any other day if symptoms re-occurred

Therapeutic efficacy study of the fixed combination of artemether-lumefantrine ( 20 mg artemether/ 120 mg lumefantrine) administered orally twice a day for three consecutive days. The number of tablets to be administered at each dosing day will be based on body weight as per standard of care. Patients will be seen daily for the first three days and then return to the health center weekly (day 7, 14, 21 and 28) for clinical and parasitological evaluation or any other day if symptoms re-occurred.

Eligibility

Sex/Gender

All

Age

6 Months to 11 Years

Healthy volunteers

Inclusion criteria

Age between 6 months to 11 years (inclusive); Monoinfection with P falciparum, microscopically confirmed Parasitaemia between 500-200,000 per microliter (asexual forms) Axillary temperature equal or greater than 37.5 degrees C; Able to swallow oral medication; Capable and willing to fulfill protocol requirements, including the schedule of assessments for the duration of the study; Provide written informed consent (parent or guardian)

Exclusion criteria

Presence of general danger and signs in children under 5 years or signs of severe falciparum malaria; Mixed or mono-infection with another Plasmodium species detected by microscopy; History of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments(s); Severe malnutrition (per WHO definition); Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea); Regular medication, which may interfere with antimalarial pharmacokinetics

Outcome results