Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg

NCT01619878 | Completed Phase 2 Results

• 3 other identifiers: CCOA566B23062011-005852-332011-005858-33
• Study Type: interventional
• Target: 20
• Locations: 5 countries
• Sites: 7

Brief Summary

The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants \< 5 kg of body weight (BW) with uncomplicated falciparum malaria.

Conditions

Acute Uncomplicated Falciparum Malaria

Keywords

plasmodium; P. falciparum; malaria; infant; neonate

Outcome Measures

Primary Outcomes (1)

• Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate

  Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.

  28 days

Secondary Outcomes (8)

• Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42

  Day 14 and 42

• Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42

  Day 3, 7, 14, 28 and 42

• Percent Change of Parasite Count From Baseline at 24 Hours

  baseline, 24 hours

• Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline

  48 hours

• Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline

  72 hours

Study Arms (1)

Cohort 1

EXPERIMENTAL

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age \>28 days.

Drug: Artemether-lumefantrine (COA566)

Interventions

Artemether-lumefantrine (COA566) DRUG

One dispersible tablet taken orally twice a day during 3 days.

Also known as: Artemether-lumefantrine, COA566

Cohort 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Neonates / infants
• Body weight \< 5 kg
• In cohort 1, infants aged \> 28 days; in cohort 2, neonates of a term age 0 to ≤ 28 days
• Microscopically confirmed diagnosis of acute uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmodium falciparum parasitaemia of \> 1,000 and \< 100,000 parasites/µL

You may not qualify if:

• Presence of severe malaria (according to World Health Organization definition)
• Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants)
• Presence of any clinically significant neurological condition
• Presence of clinically significant abnormality of the hepatic and renal systems
• Patients who sustained a significant blood volume loss (\> 3% of calculated blood volume) in the past 30 days
• Patients unable to swallow or whose drinking is impaired
• Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease
• Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)
• Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Medicines for Malaria Venture: collaborator

Study Sites (7)

Novartis Investigative Site

Cotonou, 01 BP 107, Benin

Location

Novartis investigative site

Cotonou, Benin

Location

Novartis Investigative Site

Burkina Faso, 2208, Burkina Faso

Location

Novartis investigative site

Ouagadougou, Burkina Faso

Location

Novartis investigative site

Calabar, Nigeria

Location

Novartis investigative site

Kinshasa, Republic of the Congo

Location

Novartis investigative site

Lomé, Togo

Location

Related Publications (1)

• Tiono AB, Tinto H, Alao MJ, Meremikwu M, Tshefu A, Ogutu B, Ouedraogo A, Lingani M, Cousin M, Lefevre G, Jain JP, Duparc S, Hamed K. Increased systemic exposures of artemether and dihydroartemisinin in infants under 5 kg with uncomplicated Plasmodium falciparum malaria treated with artemether-lumefantrine (Coartem(R)). Malar J. 2015 Apr 15;14:157. doi: 10.1186/s12936-015-0682-7.

  PMID: 25886021 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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 Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 17, 2015
• Results First Posted: June 17, 2015

Record last verified: 2015-06

Locations

RE (1); TO (1); BE (2); NG (1); BU (2)