NCT00451139

Brief Summary

The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
Last Updated

March 23, 2007

Status Verified

March 1, 2007

First QC Date

March 21, 2007

Last Update Submit

March 22, 2007

Conditions

Malaria

Interventions

artemether/lumefantrineDRUG
quinineDRUG
atovaquone/proguanilDRUG

Eligibility Criteria

Age5 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged above 5 years
  • Uncomplicated falciparum malaria
  • Axillary Temperature ≥37,5°C or history of fever within the previous 24 hours
  • Ability to tolerate oral therapy
  • Informed consent by the patient or by parent/guardian for children
  • Residence in study area

You may not qualify if:

  • Known or suspected hearing deficits
  • Adequate anti-malarial treatment within the previous 7 days
  • Mixed infection
  • Danger signs and signs of severe malaria as defined by the WHO
  • Presence of severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
  • Concomitant disease masking assessment of response
  • History of allergy or intolerance against study medications
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jimma University Hospital

Jimma, Ethiopia

Location

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug CombinationQuinineatovaquone, proguanil drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsCinchona AlkaloidsAlkaloidsHeterocyclic CompoundsQuinuclidinesHeterocyclic Compounds, Bridged-RingQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Nebreed Fesseaha, MD, Dean

    Facuty of Medical Sciences Jimma University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Last Updated

March 23, 2007

Record last verified: 2007-03

Locations

ET(1)