Completed PHASE4 INTERVENTIONAL 3-arm NCT00444106

Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function

An Open-label, Randomized, Single-center, Parallel Group Study of the Effects of Artemether-lumefantrine (Coartem®) Atovaquone-proguanil (Malarone®) and Artesunate-mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older

Sponsor: Novartis

Conditions Falciparum Malaria

Interventions Artemether-lumefantrine Artesunate-mefloquine Atovaquone-proguanil

Updated 7 times since 2017 Last updated: Apr 1, 2011 Started: May 31, 2007 Primary completion: Nov 30, 2008 Completion: Nov 30, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Falciparum and Malaria, this trial is completed. The trial is conducted by Novartis and has accumulated 7 data snapshots since 2007. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

7 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE4
Sep 2024 — Present [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2021 — Jul 2024 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE4
Jan 2017 — Feb 2017 [monthly]

Completed PHASE4

First recorded

May 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Tumaco, Colombia