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Treatment of Non-falciparum Malaria

Primary Purpose

Acute Non-falciparum Malaria

Status

Completed

Phase

Not Applicable

Locations

Gabon

Study Type

Interventional

Intervention

artemether-lumefantrine

About this trial

This is an interventional treatment trial for Acute Non-falciparum Malaria

Eligibility Criteria

6 Months - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical Research Unit of the Albert Schweitzer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Parasitological cure rate on day 28

Secondary Outcome Measures

Frequency and severity of drug related adverse events

Full Information

NCT ID

NCT00725777

First Posted

July 14, 2008

Last Updated

February 16, 2012

Sponsor

Albert Schweitzer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00725777

Brief Title

Treatment of Non-falciparum Malaria

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Albert Schweitzer Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Non-falciparum Malaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

artemether-lumefantrine

Intervention Description

Standard artemether-lumefantrine treatment

Primary Outcome Measure Information:

Title

Parasitological cure rate on day 28

Time Frame

D28

Secondary Outcome Measure Information:

Title

Frequency and severity of drug related adverse events

Time Frame

D28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sabine Bélard, MD

Organizational Affiliation

Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Research Unit of the Albert Schweitzer Hospital

City

Lambaréné

State/Province

Moyen Ogooue

ZIP/Postal Code

BP 118

Country

Gabon

12. IPD Sharing Statement

Citations:

PubMed Identifier

22515681

Citation

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.

Results Reference

derived

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Treatment of Non-falciparum Malaria

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