Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
12. desember 2012 oppdatert 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
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
2 år til 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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 |
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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 |
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Eksperimentell: 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)
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Pharmaceutical form:solution for injection Route of administration: intramuscular |
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Aktiv komparator: Step 2 (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 |
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Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Parasite Reduction Ratio (PRR)
Tidsramme: at 72 hours
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at 72 hours
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Evolution of mean Parasitaemia over time (nb/µL)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2011
Primær fullføring (Faktiske)
1. januar 2012
Studiet fullført (Faktiske)
1. januar 2012
Datoer for studieregistrering
Først innsendt
26. september 2011
Først innsendt som oppfylte QC-kriteriene
30. september 2011
Først lagt ut (Anslag)
4. oktober 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. desember 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. desember 2012
Sist bekreftet
1. desember 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PDY11737
- 2010-021398-36 (EudraCT-nummer)
- U1111-1118-0694 (Annen identifikator: UTN)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .