Overview

Optimising Operational Use of Artemether-lumefantrine Comparing 3 Day Versus 5 Day

Status:
Completed
Trial end date:
2015-03-25
Target enrollment:
0
Participant gender:
All
Summary
This is a randomised two arm study, comparing artemether-lumefantrine 3 days and 5 days treatment. Patients will be randomised in blocks of ten to one of the two treatment arms. The standard regimen is twice daily for three days with a delay of at least eight hours between the first and second doses. A single of primaquine will be given to all patients on the first day of treatment for gametocytocidal activity. The initial treatment will be given under supervision, all other subsequent doses will be given to the patient to the taken at home. Patients will be followed up for nine visits over forty two days.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Oxford
Treatments:
Artemether
Artemether-lumefantrine combination
Artemether, Lumefantrine Drug Combination
Artemisinins
Lumefantrine
Criteria
Inclusion Criteria:

1. Age ≥ 6 year

2. Symptomatic malaria infection, i.e. history of fever or presence of fever >37.5°C

3. Microscopic confirmation of asexual stages of P. falciparum (may be mixed with
non-falciparum species) with parasitaemia PFT≥5/500 WBC

4. Written informed consent given to participate in the trial

Exclusion Criteria:

1. Pregnancy or lactation (urine test for β HCG to be performed on any woman of child
bearing age unless menstruating).

2. Female of 12 to 18 years of age

3. P. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells
(175,000/µL).

4. Signs or symptoms indicative of severe malaria including:

- Impaired consciousness (Blantyre Coma Score <5 or Glasgow Coma Scale <15)

- Severe anaemia (Hb% <5 mg/dl)

- Bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria,
bleeding from venepuncture sites

- Respiratory distress

- Severe jaundice

- Haemodynamic shock

5. A full course of artemether-lumefantrine treatment in the previous 28 days

6. Known hypersensitivity to artemisinins - defined as history of erythroderma/other
severe cutaneous reaction, angioedema or anaphylaxis

7. History of splenectomy