Clinical trial NCT01619878: Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Uncomplicated Falciparum Malaria
Keywords: plasmodium
P. falciparum
malaria
infant
neonate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Medicines for Malaria Venture
First posted: 2012-06-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate
timeFrame: 28 days
Secondary outcomes:
measure: Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42
timeFrame: Day 14 and 42
measure: Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42
timeFrame: Day 3, 7, 14, 28 and 42
measure: Percent Change of Parasite Count From Baseline at 24 Hours
timeFrame: baseline, 24 hours
measure: Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline
timeFrame: 48 hours
measure: Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline
timeFrame: 72 hours
measure: Time to Parasite Clearance (PCT)
timeFrame: Up to 7 days
measure: Time to Fever Clearance (FCT)
timeFrame: Up to 7 days
measure: Time to Gametocyte Clearance (GCT)
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Cotonou
country: Benin
facility: Novartis Investigative Site
city: Cotonou
country: Benin
facility: Novartis investigative site
city: Burkina Faso
country: Burkina Faso
facility: Novartis Investigative Site
city: Ouagadougou
country: Burkina Faso
facility: Novartis investigative site
city: Kinshasa
country: Congo
facility: Novartis investigative site
city: Calabar
country: Nigeria
facility: Novartis investigative site
city: Lome
country: Togo
facility: Novartis investigative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.