Treatment of Non-falciparum Malaria | NCT00725777

Studies
Treatment of Non-falciparum Malaria

NCT00725777

Sponsor

Albert Schweitzer Hospital

Status

Completed

Last Update Posted

Feb 17, 2012Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Acute Non-falciparum Malaria

Interventions

artemether-lumefantrine

Countries

Gabon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jul 14, 2008

First Submission Date that Met QC Criteria

Jul 28, 2008

First Posted Date

Jul 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2012

Last Update Posted Date

Feb 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: artemether-lumefantrine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
artemether-lumefantrine	Drug	Standard artemether-lumefantrine treatment	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parasitological cure rate on day 28		D28

Secondary Outcomes

Measure	Description	Time Frame
Frequency and severity of drug related adverse events		D28

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sabine Bélard, MD	Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Research Unit of the Albert Schweitzer Hospital		Lambaréné	Moyen-Ogooué Province	BP 118	Gabon

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22515681	Derived	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.

ID	Term
D000077549	Artemether
D037621	Artemisinins
D017382	Reactive Oxygen Species
D005609	Free Radicals