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NCT04215991 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
A Phase 2 study of Gram-negative Bacterial Infections and Hospital Acquired Bacterial Pneumonia (HABP), sponsored by Shionogi.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
- 20
- Study locations
NCT04215991: Completed Phase 2 study of Gram-negative Bacterial Infections and Hospital Acquired Bacterial Pneumonia (HABP), sponsored by Shionogi.
NCT04215991 is a Phase 2 study of Gram-negative Bacterial Infections and Hospital Acquired Bacterial Pneumonia (HABP) that has completed, run by Shionogi. The registered enrollment target is 91 participants, below the 420-participant average among 4 other Gram-negative Bacterial Infections trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04215991, a Phase 2 study of Gram-negative Bacterial Infections and Hospital Acquired Bacterial Pneumonia (HABP), has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric participants 3 months to \< 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP).
Conditions Studied
Interventions
- DRUG Standard of Care
- DRUG Cefiderocol
Study Locations (20)
Other
- JSC "EVEX Medical Corporation"- M Lashvili Childrens Central Hospital - Tbilisi
- Ltd Unimedi Kakheti Childrens New Clinic - Tbilisi
- University Hospital "ATTIKON" 3rd Pediatric Clinic of NKUA - Chaïdári
- Hippokration Hospital 3rd Pediatric Clinic of AUTH Konstantinoupoleos 49 - Thessaloniki
- General Hospital of Thessaloniki Papageorgiou - Thessaloniki
- Hospital of Lithuanian University of Health Sciences Kauno klinikos - Kaunas
- Klaipeda Children's Hospital - Klaipėda
- Vilnius University Hospital Santaros Klinikos - Vilnius
- Instituto Nacional de Pediatría "Laboratorio de la Unidad de Apoyo a la Investigación Clínica", Planta Baja Col. Insurgentes Cuicuilco, Delegacion Coyoacán Av. Insurgentes Sur 3700-C - Mexico City
- Hospital de Especialidades Ped Via España y Calle Zarak - Panama City
- Hospital del Niño, Epidemiologia - Panama City
- Chong Hua Hospital - Cebu City
- Western Visayas and Medical Center - Iloilo City
- Manila Doctor's Hospital - Manila
Iowa
- University of Iowa Stead Family Children's Hospital - Iowa City
Texas
- Cook Children's Medical Center - Fort Worth
Queensland
- Queensland Children's Health Precinct Level 8, Centre for Children's Health Research 62 Graham Street - South Brisbane
Crete
- Heraklion University General Hospital - Heraklion
Thessaly
- University General Hospital of Larissa - Larissa
Jalisco
- Hospital Civil de Guadalajara Hospital 278, El retiro, Torre Piso 10, Infectología Ped. - Guadalajara
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2020-02-19 |
| Est. Completion | 2024-09-17 |
| Phase | Phase 2 |
What the finished NCT04215991 record still lists
NCT04215991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 420-participant average among 4 other Gram-negative Bacterial Infections trials with a reported enrollment target (78% lower).
The record links to 4 conditions, with Gram-negative Bacterial Infections appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT04215991 names 20 study sites across 7 states, led by Other, Iowa, Texas.
Frequently Asked Questions
What is clinical trial NCT04215991 about?
NCT04215991 is a clinical study titled "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants". The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to \< 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and afte...
What is the current status of trial NCT04215991?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2020-02-19. Estimated completion is 2024-09-17.
What conditions does trial NCT04215991 study?
This clinical trial studies the following conditions: Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP).
What interventions are being tested in trial NCT04215991?
The interventions under investigation include: Standard of Care (DRUG), Cefiderocol (DRUG).
Who is sponsoring clinical trial NCT04215991?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04215991 being conducted?
This trial has 20 study locations across Iowa, Texas, Queensland, Crete, Thessaly. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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