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Completed

NCT Number: NCT01619878

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

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.

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Key information

Conditions

Acute Uncomplicated Falciparum Malaria Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Novartis Investigative Site, Cotonou, Benin

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Artemether-lumefantrine (COA566)

Drug

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

Other names: Artemether-lumefantrine, COA566

Primary outcomes

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

    Time frame: 28 days

    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.

Secondary outcomes

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

    Time frame: Day 14 and 42

    Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.

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

    Time frame: Day 3, 7, 14, 28 and 42

    Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment.

  3. Percent Change of Parasite Count From Baseline at 24 Hours

    Time frame: baseline, 24 hours

    Percent change of parasite count from baseline at 24 hours

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

    Time frame: 48 hours

    Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.

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

    Time frame: 72 hours

    Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline.

  6. Time to Parasite Clearance (PCT)

    Time frame: Up to 7 days

    Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.

  7. Time to Fever Clearance (FCT)

    Time frame: Up to 7 days

    Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours.

  8. Time to Gametocyte Clearance (GCT)

    Time frame: Up to 7 days

    Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

  • Medicines for Malaria Venture

Registry information

Official study title

An Open-label, Single-arm Study to Evaluate the Efficacy, Safety and PK of Artemether-lumefantrine Dispersible Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants <5 kg Body Weight

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 14, 2012
Registry last updated
Jun 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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