- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01445938
Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Cotonou, Benin
- Investigational Site Number 204001
-
-
-
-
-
Ouagadougou, Burkina Faso
- Investigational Site Number 854001
-
-
-
-
-
Libreville, Gabon
- Investigational Site Number 266001
-
-
-
-
-
Kisumu, Kenia
- Investigational Site Number 404001
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Step 1 (SAR97276A od)
1 group of paediatric patients will receive 0.5 mg/kg SAR97276A administration once daily (od) for 3 days
|
Pharmaceutical form:solution for injection Route of administration: intramuscular |
Kokeellinen: Step 1 (SAR97276A bid)
1 group of paediatric patients will receive 0.25 mg/kg SAR97276A administration twice daily (bid) for 3 days
|
Pharmaceutical form:solution for injection Route of administration: intramuscular |
Active Comparator: Step 1 (ACTs)
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
|
Pharmaceutical form:tablet Route of administration: oral |
Kokeellinen: 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 |
Active Comparator: Step 2 (ACTs)
1 group of paediatric patients will receive arthemeter + lumefantrine (ACTs) bid for 3 days
|
Pharmaceutical form:tablet Route of administration: oral |
Kokeellinen: 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)
|
Pharmaceutical form:solution for injection Route of administration: intramuscular |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Parasite Reduction Ratio (PRR)
Aikaikkuna: at 72 hours
|
at 72 hours
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Evolution of mean Parasitaemia over time (nb/µL)
Aikaikkuna: every 6 hours from baseline up to 72 hours (day 4)
|
every 6 hours from baseline up to 72 hours (day 4)
|
Evolution of mean Gametocytes count over time (nb/µL)
Aikaikkuna: from baseline to end of study (day 28 ± 2)
|
from baseline to end of study (day 28 ± 2)
|
Fever Clearance (time to reach Temperature < 38°C)
Aikaikkuna: every 6 hours from baseline up to 72 hours (day 4)
|
every 6 hours from baseline up to 72 hours (day 4)
|
General conditions improvement: mean total symptom score over time
Aikaikkuna: every 6 hours from baseline up to 72 hours (day 4)
|
every 6 hours from baseline up to 72 hours (day 4)
|
SAR97276 pharmacokinetic profile in plasma and blood
Aikaikkuna: from baseline up to 12 hours after the last study drug intake on (Day 3
|
from baseline up to 12 hours after the last study drug intake on (Day 3
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- PDY11737
- 2010-021398-36 (EudraCT-numero)
- U1111-1118-0694 (Muu tunniste: UTN)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .