Optimizing PreTerm Infant Ampicillin Dosing (OPTI-Amp)
An Open-label, Pharmacokinetic and Safety Trial Optimizing PreTerm Infant Ampicillin Dosing
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safety receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours). The main questions it aims to answer are:
- Does short-course ampicillin provide high enough levels of ampicillin at 48 hours?
- Is short-course ampicillin safe for preterm infants to receive?
Preterm infants who are being prescribed ampicillin by their doctor and enroll in the study will stop ampicillin after a shorter than typical course, and researchers will collect blood samples to measure their ampicillin levels and follow them clinically to see how they do after receiving short-course ampicillin.
Participants will:
- stop ampicillin earlier than 48 hours (between 24 to 36 hours, depending on how premature they are and the dosing of ampicillin their doctor has prescribed)
- have one or more blood samples collected, including one around 48 hours from when they started ampicillin
- have their data collected until 30 days after they receive short-course ampicillin, or until hospital discharge, whichever is sooner
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OPTI-Amp is a prospective, open-label, non-randomized pharmacokinetic and safety trial of short-course ampicillin administered to preterm neonates in the Neonatal Intensive Care Unit (NICU) at Duke.
The objectives of the study are to 1) evaluate whether short-course ampicillin provides therapeutic exposures for 48 hours from ampicillin initiation for preterm neonates undergoing evaluation of early onset sepsis (EOS) and 2) evaluate the safety of short-course ampicillin compared to standard empiric ampicillin. The prescribing of drugs to infants will not be part of this protocol.
Approximately 60 neonates ≤34 weeks gestational age and <7 days postnatal age at the time of screening, who are receiving empiric ampicillin prescribed per standard of care (SOC) by their treating provider will be enrolled in the study. Participants will be in the study up to 30 days or hospital discharge, whichever is sooner. Enrolled infants who receive short-course ampicillin will have a pharmacokinetic sample collected at 48 (+/-2) hours from the time that ampicillin was initiated. Additional opportunistic pharmacokinetic (PK) samples can be collected between enrollment and 72 hours from ampicillin initiation if the patient is receiving other SOC labs; however, these are not required. Demographic information, clinical data, and biospecimen information (including date and time of sample collection) will also be collected for enrolled participants.
All enrolled infants will be in the safety population. Those with at least one PK sample will be included in the PK population. In addition to the risks of blood drawing and loss of confidentiality, there may be a risk of under treatment of EOS if clinical cultures result positive after ampicillin discontinuation and therapeutic exposure is not maintained between 24 or 36 hours until 48 hours. Participants that fall under the latter situation will either not be enrolled in the study or will be withdrawn as determined by the study PI.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Angelique Boutzoukas, MD, MPH
- Numéro de téléphone: 919-668-4733
- E-mail: angelique.boutzoukas@duke.edu
Lieux d'étude
-
-
North Carolina
-
Durham, North Carolina, États-Unis, 27705
- Recrutement
- Duke Health Neonatal Intensive Care Unit
-
Contact:
- Stefany Olague, MPH
- E-mail: smalltrials-CRC@duke.edu
-
Contact:
- Angelique E Boutzoukas, MD, MPH
- Numéro de téléphone: 919-668-4733
- E-mail: angelique.boutzoukas@duke.edu
-
Chercheur principal:
- Angelique E Boutzoukas, MD, MPH
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- Documented informed consent from parent/guardian
- Infants admitted to the Duke Neonatal Intensive Care Unit (NICU)
- less than or equal to 34 completed weeks gestational age (GA) at birth and < 7 days of life at time of screening
- Prescribed ampicillin by provider per standard of care for evaluation of early onset sepsis
Exclusion Criteria:
- Infant on extracorporeal support (e.g., ECMO)
- Positive blood culture or other confirmed infection
- At time of consent, infants with GA <28 completed weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28 to 34 completed weeks who have received > 32 to 36 hours of ampicillin, depending on dosing regimen
- Has major congenital abnormalities where survival to 30 days of life is not expected
- Receives a course of ampicillin that is longer (i.e., more doses) than the short-course defined regimen for their GA
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Short-course Ampicillin
Infants enrolled in the trial receive short-course empiric ampicillin (24 to 36 hours, depending on gestational age and prescribed dosing regimen), rather than a standard (48 hour) empiric ampicillin course
|
preterm infants receive less than 48 hours of prescribed ampicillin (i.e., a "short-course" ampicillin regimen) to provide the desired 48 hours of therapeutic exposures
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total plasma ampicillin concentration
Délai: data will be collected up to 50 hours from the first dose of ampicillin
|
Total plasma ampicillin concentration at 48(+/-) 2 hours after ampicillin initiation, following a single gestational age defined short-course with no further ampicillin administration.
Target attainment defined as total ampicillin concentration of ≥1 µg/mL.
The short-course regimen is considered successful if target attainment is achieved in ≥90% of the overall study population.
|
data will be collected up to 50 hours from the first dose of ampicillin
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Serious, unexpected, suspected adverse reactions to ampicillin
Délai: Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
|
Adverse events related to study procedures
Délai: Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
|
All-cause mortality at 30 days
Délai: Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
|
Antibiotic re-initiation within 7 days of short-course ampicillin
Délai: Data will be collected until 7 days from short-course ampicillin
|
Data will be collected until 7 days from short-course ampicillin
|
|
Culture-confirmed bacteremia within 7 days of short-course ampicillin
Délai: Data will be collected until 7 days from short-course ampicillin
|
Data will be collected until 7 days from short-course ampicillin
|
|
Necrotizing enterocolitis within 30 days of short-course ampicillin
Délai: Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
Data will be collected until 30 days from short-course ampicillin, or until hospital discharge
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Pro00119855
- 1K23HD113839 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .