Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
This study is currently recruiting participants.
Verified June 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Collaborator:
Medicines for Malaria Venture
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01619878
First received: June 12, 2012
Last updated: June 12, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Uncomplicated Falciparum Malaria |
Drug: COA566 Drug: Artemether-lumefantrine dispersible tablet |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Polymerase Chain Reaction (PCR) corrected 28 day parasitological cure rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]Percent of patients 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 Outcome Measures:
- Polymerase Chain Reaction (PCR) corrected parasitological cure rate at day 14 [ Time Frame: Baseline and day 14 ] [ Designated as safety issue: No ]Percent of patients with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
- Polymerase Chain Reaction (PCR) corrected parasitological cure rate at day 42 [ Time Frame: Baseline and day 42 ] [ Designated as safety issue: No ]Percent of patients with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.
- Parasitological uncorrected cure rate at day 3 [ Time Frame: Baseline and day 3 ] [ Designated as safety issue: No ]Percent of patients with clearance of asexual parasites at day 3 after initiating study treatment.
- Parasitological uncorrected cure rate at day 7 [ Time Frame: Baseline and day 7 ] [ Designated as safety issue: No ]Percent of patients with clearance of asexual parasites at day 7 after initiating study treatment.
- Parasitological uncorrected cure rate at day 14 [ Time Frame: Baseline and day 14 ] [ Designated as safety issue: No ]Percent of patients with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14.
- Parasitological uncorrected cure rate at day 28 [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]Percent of patients with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28.
- Parasitological uncorrected cure rate at day 42 [ Time Frame: Baseline and day 42 ] [ Designated as safety issue: No ]Percent of patients with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 42.
- Parasite reduction at 24 hours after treatment initiation [ Time Frame: Baseline and 24 hours ] [ Designated as safety issue: No ]Average percent change in parasite density at 24 hours from baseline.
- Number of patients with parasitaemia at 72 hours after treatment initiation greater than or equal to 25 percent of count at baseline [ Time Frame: Baseline and 72 hours ] [ Designated as safety issue: No ]Percent of patients with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline.
- Number of patients with parasitaemia at 48 hours after treatment initiation greater than at baseline [ Time Frame: Baseline and 48 hours ] [ Designated as safety issue: No ]Percent of patients with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.
- Time to parasite clearance (PCT) [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.
- Time to fever clearance (FCT) [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]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.
- Time to gametocyte clearance (GCT) [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.
- Gametocyte carriage over time [ Time Frame: Up to 42 days ] [ Designated as safety issue: No ]Number of patients with gametocyte carriage.
- Incidence of serious adverse events (SAEs) [ Time Frame: up to day 365 ] [ Designated as safety issue: Yes ]Percent of patients with serious adverse events (SAEs).
- Incidence of adverse events (AEs) [ Time Frame: Up to day 42 ] [ Designated as safety issue: Yes ]Percent of patients with adverse events (AEs).
- Biochemical and haematological changes [ Time Frame: Up to day 42 ] [ Designated as safety issue: Yes ]Percent of patients with biochemical and haematological changes.
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Infants aged >28 days.
|
Drug: COA566
One dispersible tablet taken orally twice a day during 3 days.
Drug: Artemether-lumefantrine dispersible tablet
One dispersible tablet taken orally twice a day during 3 days.
|
|
Experimental: Cohort 2
Neonates of a term age 0 to ≤28 days
|
Drug: COA566
One dispersible tablet taken orally twice a day during 3 days.
Drug: Artemether-lumefantrine dispersible tablet
One dispersible tablet taken orally twice a day during 3 days.
|
Eligibility| Ages Eligible for Study: | up to 6 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619878
Contacts
| Contact: Novartis Pharmaceuticals, Study Director | +41613241111 | |
| Contact: Novartis Pharmaceuticals |
Locations
| Benin | |
| Novartis investigative site | Not yet recruiting |
| Cotonou, Benin | |
| Novartis Investigative Site | Recruiting |
| Cotonou, Benin, 01 BP 107 | |
| Burkina Faso | |
| Novartis Investigative Site | Recruiting |
| Burkina Faso, Burkina Faso, 2208 | |
| Novartis investigative site | Not yet recruiting |
| Ouagadougou, Burkina Faso | |
| Novartis Investigative Site | Not yet recruiting |
| Ouagadougou 01, Burkina Faso | |
| Congo | |
| Novartis investigative site | Not yet recruiting |
| Kinshasa, Congo | |
| Nigeria | |
| Novartis investigative site | Not yet recruiting |
| Calabar, Nigeria | |
| Togo | |
| Novartis investigative site | Not yet recruiting |
| Lome, Togo | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Medicines for Malaria Venture
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01619878 History of Changes |
| Other Study ID Numbers: | CCOA566B2306, 2011-005852-33, 2011-005858-33 |
| Study First Received: | June 12, 2012 |
| Last Updated: | June 12, 2013 |
| Health Authority: | United States: Food and Drug Administration Burkina Faso: Ministère de la Santé S/C Direction générale de la pharmacie, du médicament et des laboratoires (DGPML). |
Keywords provided by Novartis:
|
plasmodium P. falciparum malaria infant neonate |
Additional relevant MeSH terms:
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Artemether Artemisinins Lumefantrine Artemether-lumefantrine combination Antifungal Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents Coccidiostats Schistosomicides Antiplatyhelmintic Agents Anthelmintics |
ClinicalTrials.gov processed this record on June 18, 2013