Text Size

Treatment of Non-falciparum Malaria

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Ramharter, Albert Schweitzer Hospital
ClinicalTrials.gov Identifier:
NCT00725777
First received: July 14, 2008
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Acute Non-falciparum Malaria
 Drug: artemether-lumefantrine

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

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Albert Schweitzer Hospital:

Primary Outcome Measures:
  • Parasitological cure rate on day 28 [ Time Frame: D28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of drug related adverse events [ Time Frame: D28 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 2008
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: artemether-lumefantrine
Standard artemether-lumefantrine treatment

  Eligibility

Ages Eligible for Study:   6 Months to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725777

Locations
Gabon
Medical Research Unit of the Albert Schweitzer Hospital
Lambaréné, Moyen Ogooue, Gabon, BP 118
Sponsors and Collaborators
Albert Schweitzer Hospital
Investigators
Principal Investigator: Sabine Bélard, MD Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné
  More Information

No publications provided by Albert Schweitzer Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Ramharter, Ass. Prof. PD, Albert Schweitzer Hospital
ClinicalTrials.gov Identifier: NCT00725777     History of Changes
Other Study ID Numbers: IDC-08-01
Study First Received: July 14, 2008
Last Updated: February 16, 2012
Health Authority: Gabon: Ministry of Health

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artemether
Artemisinins
Lumefantrine
Artemether-lumefantrine combination
Antifungal Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on May 16, 2013