Treatment of Non-falciparum Malaria

Acute Non-falciparum Malaria Clinical Trial

Official title:

Efficacy and Safety of Artemether Lumefantrine Combination Therapy for the Treatment of Malaria Due to Plasmodium Ovale, Plasmodium Malariae, and Mixed Plasmodium Infections in Gabon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725777
• Other study ID #: IDC-08-01
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: February 16, 2012
• Start date: July 2008
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Albert Schweitzer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gabon: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 60 Years

Eligibility

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:

• 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Non-falciparum Malaria
• Malaria

Intervention

Drug:
• artemether-lumefantrine
Standard artemether-lumefantrine treatment

Locations

Country	Name	City	State
Gabon	Medical Research Unit of the Albert Schweitzer Hospital	Lambaréné	Moyen Ogooue

Sponsors (1)

Lead Sponsor	Collaborator
Albert Schweitzer Hospital

Country where clinical trial is conducted

Gabon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasitological cure rate on day 28		D28	No
Secondary	Frequency and severity of drug related adverse events		D28	Yes