CompletedNCT00725777Updated Feb 17, 2012

Treatment of Non-falciparum Malaria

An interventional study of artemether-lumefantrine in Acute Non-falciparum Malaria, sponsored by Albert Schweitzer Hospital. Completed at 1 site in Gabon. Open to participants aged 6 Months to 60 Years. Per ClinicalTrials.gov, last updated 2012-02-17.

Sponsored by Albert Schweitzer Hospital · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Not applicable
Ages: 6 Months to 60 Years
Sex: All

Study summary

Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed.

Conditions studied

Acute Non-falciparum Malaria

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Malaria 1,299

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 40 is below the median of 220 across 1,027 interventional studies indexed under Malaria.

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Lead sponsor

Albert Schweitzer Hospital is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Months to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female patients between the age of 6 months and 60 years and with a minimum of 5kg bodyweight
Presence of uncomplicated malaria confirmed by: i)fever or history of fever in the previous 4 days, and ii)positive microscopy of P. malariae or P. ovale or mixed infection with P.falciparum with parasite density > 50-200000/μl of blood
Written informed consent

Exclusion criteria

Exclusion Criteria:

Patients with presence of other clinical conditions requiring hospitalization
Presence of other febrile conditions
Presence of significant anemia, defined by hemoglobin \< 7g/dl
Known history of hypersensitivity,allergic or adverse reactions to artemether or lumefantrine
Intake of any antimalarial or antibiotics with known antimalarial activity in the preceding 2 weeks
Pregnant and breast feeding females

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 40 participants (actual)

Study arms

Experimental
A
Drug: artemether-lumefantrine

Interventions

Drugartemether-lumefantrine
Standard artemether-lumefantrine treatment

What researchers measure

Primary outcomes

Parasitological cure rate on day 28
Time frame: D28

Secondary outcomes

Frequency and severity of drug related adverse events
Time frame: D28

Study locations

1 site

Medical Research Unit of the Albert Schweitzer Hospital
Lambaréné, Moyen Ogooue BP 118, Gabon

References and documents

Publications

Mombo-Ngoma G, Kleine C, Basra A, Wurbel H, Diop DA, Capan M, Adegnika AA, Kurth F, Mordmuller B, Joanny F, Kremsner PG, Ramharter M, Belard S. Prospective evaluation of artemether-lumefantrine for the treatment of non-falciparum and mixed-species malaria in Gabon. Malar J. 2012 Jul 10;11:120. doi: 10.1186/1475-2875-11-120. PubMed 22515681 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00725777
Lead sponsor: Albert Schweitzer Hospital
Responsible party: Michael Ramharter (Ass. Prof. PD, Albert Schweitzer Hospital) — Principal investigator
First posted: Jul 30, 2008
Start date: Jul 2008
Primary completion: Dec 2011
Completion: Feb 2012
Last update: Feb 17, 2012

Study contacts

Sabine Bélard, MD

principal investigator · Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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