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

NCT00444106 | Completed Phase 4 Results

• 1 other identifier: CCOA566A2417
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the potential effects of artemether- lumefantrine on the auditory function

Conditions

Malaria; Falciparum

Keywords

Malaria; hearing; co-artemether; auditory; Plasmodium falciparum; marsh fever; Plasmodium infections; remittent fever; paludism; artemether; artemisinins; benflumetol; lumefantrine

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test)

  To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An "auditory nerve abnormality" is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups.

  7 days

Secondary Outcomes (3)

• Auditory Changes Following 3 Days of Treatment at Days 3, 7, 28, and 42 Days as Assessed by Pure Tone Thresholds Assessments (a Type of Hearing Test)

  Baseline (Day 1), 3, 7, 28 and Day 42

• Relationship Between Changes in Auditory Function and Treatment Groups

  From Baseline to Day 7

• Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42

  Days 14, 28 and 42

Study Arms (3)

Artemether-lumefantrine (Coartem)

EXPERIMENTAL

Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days, dosage dependent on body weight.

Drug: Artemether-lumefantrine

Atovaquone-proguanil (Malarone)

ACTIVE COMPARATOR

Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days, dosage dependent on body weight.

Drug: Atovaquone-proguanil

Artesunate-mefloquine

ACTIVE COMPARATOR

Artesunate-mefloquine tablets containing 50 mg artesunate (Plasmotrim) and 250 mg mefloquine (Mephaquin). Artesunate 4 mg/kg/day (for 3 days) and mefloquine 25 mg/kg/day (days 2 and 3) total dose was given once daily dependent upon body weight.

Drug: Artesunate-mefloquine

Interventions

Artesunate-mefloquine DRUG

Also known as: Plasmotrim, Mephaquin

Artesunate-mefloquine

Atovaquone-proguanil DRUG

Also known as: Malarone

Atovaquone-proguanil (Malarone)

Artemether-lumefantrine DRUG

Also known as: Coartem

Artemether-lumefantrine (Coartem)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Accepts Healthy Volunteers
• P. falciparum parasitemia between 1,000 and 100,000 parasites/μl
• History of fever or presence of fever (temperature ≥ 37.5°C)

You may not qualify if:

• Signs/symptoms of severe/complicated malaria
• Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months
• History of any drug-related hearing impairment
• Abnormal hearing function at study entry
• Exposure to sustained loud noises, by self-report, within the past 24 hours
• Present ear problems
• Pregnant or lactating (urine test for β-HCG) to be performed on any woman of child bearing age)

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigational Site

Tumaco, Colombia

Location

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Mefloquine; atovaquone, proguanil drug combination; Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 7, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 5, 2011
• Results First Posted: March 16, 2011

Record last verified: 2011-04

Locations

CO (1)