Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
12 december 2012 uppdaterad av: Sanofi
An Open-label, Randomized Multicenter Study to Investigate the Anti-parasitic Activity, Pharmacokinetic and Safety of IM SAR97276A With Oral ACTs as Positive Control in Children Presenting With Symptomatic Plasmodium Falciparum Uncomplicated Malaria
Primary Objective:
To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria
Secondary Objectives:
- To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs)
- To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria
- To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria
- To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The total duration per patients will last approximately 28 ± 2 days broken down as follows:
- A screening phase up to 12-hours
- A 28 ± 2 days study period
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Cotonou, Benin
- Investigational Site Number 204001
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Ouagadougou, Burkina Faso
- Investigational Site Number 854001
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Libreville, Gabon
- Investigational Site Number 266001
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Kisumu, Kenya
- Investigational Site Number 404001
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
2 år till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion criteria:
- Patients diagnosed with symptomatic infection by Plasmodium falciparum microscopically confirmed in blood smear at Day-1 visit
- Fever (tympanic or rectal temperature ≥ 38 C) or documented history of fever within the last 24h
- Asexual parasitemia of ≥ 2 000 parasites/μL in blood smear at D-1 visit
- Signed Informed Consent Form by the parents or legal guardian
- Age: 12 to 17 years old for step 1
- Age: 2 to 11 years old for step 2 and step 3
Exclusion criteria:
- Participation in another clinical trial within the last 3 months or participation within a different cohort in this PDY11737 clinical trial or participation to previous trial with SAR97276
- Documented history of adequate treatment with antimalarials expected to be effective within the preceding 72 hours
- Severe concomitant disease (including concomitant febrile illnesses or infection)
- Any sign suggestive of severe malaria
- Severe malnutrition
- Asexual parasitemia: Plasmodium falciparum > 100,000 parasites/μL in blood smear at D-1 visit
- Previous treatment within 3 weeks prior to inclusion, and concomitant treatment with potent CYP3A4 inhibitors or CYP3A4 inducers or CYP2D6 substrates or potent CYP2D6 inhibitors
- Known serious adverse event reaction or hypersensitivity to Artemisinin-Based Combination Therapy (ACTs) or any contraindications from the positive control therapy (Artemisinin Combined Treatments) or warning/precaution of use as defined in the respective National Product Labeling
- Pregnant or breast-feeding women
- Women of childbearing potential not protected by effective contraceptive method of birth control, or not willing to use an effective contraceptive(s) method(s) for the duration of the study (e.g.: double barrier method), and/or who are unwilling or unable to be tested for pregnancy,
- CPK above 3 ULN,
- Underlying hepatobiliary disease or ALT>3 ULN.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Step 1 (SAR97276A od)
1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days
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Pharmaceutical form:solution for injection Route of administration: intramuscular |
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Experimentell: Step 1 (SAR97276A bid)
1 group of paediatric patients will receive 0.25 mg/kg SAR97276A administration twice daily (bid) for 3 days
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Pharmaceutical form:solution for injection Route of administration: intramuscular |
|
Aktiv komparator: Step 1 (ACTs)
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
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Pharmaceutical form:tablet Route of administration: oral |
|
Experimentell: Step 2 (SAR97276A)
1 or 2 groups of paediatric patients will receive SAR97276A once daily (od) or twice a day (bid) administration for 3 days (the choice of the od or bid regimen will be based on the results obtained in step 1)
|
Pharmaceutical form:solution for injection Route of administration: intramuscular |
|
Aktiv komparator: Step 2 (ACTs)
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
|
Pharmaceutical form:tablet Route of administration: oral |
|
Experimentell: Step 3 (SAR97276A)
1 group of paediatric patients (2 to 11 years old) will receive: SAR97276A od or bid administration for 3 days (depending on results of step 1)
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Pharmaceutical form:solution for injection Route of administration: intramuscular |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Parasite Reduction Ratio (PRR)
Tidsram: at 72 hours
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at 72 hours
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Evolution of mean Parasitaemia over time (nb/µL)
Tidsram: every 6 hours from baseline up to 72 hours (day 4)
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every 6 hours from baseline up to 72 hours (day 4)
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Evolution of mean Gametocytes count over time (nb/µL)
Tidsram: from baseline to end of study (day 28 ± 2)
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from baseline to end of study (day 28 ± 2)
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Fever Clearance (time to reach Temperature < 38°C)
Tidsram: every 6 hours from baseline up to 72 hours (day 4)
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every 6 hours from baseline up to 72 hours (day 4)
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General conditions improvement: mean total symptom score over time
Tidsram: every 6 hours from baseline up to 72 hours (day 4)
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every 6 hours from baseline up to 72 hours (day 4)
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SAR97276 pharmacokinetic profile in plasma and blood
Tidsram: from baseline up to 12 hours after the last study drug intake on (Day 3
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from baseline up to 12 hours after the last study drug intake on (Day 3
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2011
Primärt slutförande (Faktisk)
1 januari 2012
Avslutad studie (Faktisk)
1 januari 2012
Studieregistreringsdatum
Först inskickad
26 september 2011
Först inskickad som uppfyllde QC-kriterierna
30 september 2011
Första postat (Uppskatta)
4 oktober 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 december 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 december 2012
Senast verifierad
1 december 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PDY11737
- 2010-021398-36 (EudraCT-nummer)
- U1111-1118-0694 (Annan identifierare: UTN)
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