Phase 3
Completed N=20
Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
Acute Uncomplicated Falciparum Malaria
Source: ClinicalTrials.gov NCT01619878 ↗
Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Jun 2015
Primary outcomePrimary: Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate — 16 number of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate |
16 | — |
| SECONDARY Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42 |
16; 16 | — |
| SECONDARY Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42 |
20; 16; 16; 10; 7 | — |
| SECONDARY Percent Change of Parasite Count From Baseline at 24 Hours |
-99.4 | — |
| SECONDARY Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline |
— | — |
| SECONDARY Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline |
— | — |
| SECONDARY Time to Parasite Clearance (PCT) |
29.1 | — |
| SECONDARY Time to Fever Clearance (FCT) |
4.02 | — |
| SECONDARY Time to Gametocyte Clearance (GCT) |
36.32 | — |
Eligibility Criteria
Inclusion Criteria
- Neonates / infants
- Body weight 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 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.
Data sourced from ClinicalTrials.gov (NCT01619878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.