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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
NCT04215991 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04215991
The ClinicalTrials.gov registry entry for NCT04215991 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shionogi, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04215991 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Iowa, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04215991?
The interventions under investigation include: Standard of Care (DRUG), Cefiderocol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04215991?
This trial is sponsored by Shionogi, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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