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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01619878 |
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Date of registration:
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12/06/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
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Scientific title:
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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 |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01619878 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Benin
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Burkina Faso
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Congo
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Nigeria
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Togo
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Uncomplicated Falciparum Malaria
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Intervention(s)
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Drug: Artemether-lumefantrine (COA566)
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Primary Outcome(s)
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Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate
[Time Frame: 28 days]
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Secondary Outcome(s)
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Time to Gametocyte Clearance (GCT)
[Time Frame: Up to 7 days]
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Percent Change of Parasite Count From Baseline at 24 Hours
[Time Frame: baseline, 24 hours]
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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]
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Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline
[Time Frame: 48 hours]
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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]
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Time to Fever Clearance (FCT)
[Time Frame: Up to 7 days]
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Time to Parasite Clearance (PCT)
[Time Frame: Up to 7 days]
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Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42
[Time Frame: Day 14 and 42]
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Secondary ID(s)
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2011-005852-33
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2011-005858-33
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CCOA566B2306
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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