# A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

> **NCT04335539** · PHASE2 · COMPLETED · sponsor: **Shionogi** · enrollment: 53 (actual)

## Conditions studied

- Gram-negative Bacterial Infections
- Bloodstream Infections (BSI)
- Complicated Intra-abdominal Infection (cIAI)
- Hospital Acquired Pneumonia (HAP)
- Ventilator-acquired Pneumonia
- Complicated Urinary Tract Infection (cUTI)
- Sepsis

## Interventions

- **DRUG:** Cefiderocol
- **DRUG:** Standard of Care

## Key facts

- **NCT ID:** NCT04335539
- **Lead sponsor:** Shionogi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-08-21
- **Primary completion:** 2023-02-06
- **Final completion:** 2023-02-06
- **Target enrollment:** 53 (ACTUAL)
- **Last updated:** 2026-02-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04335539

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04335539, "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants". Retrieved via AI Analytics 2026-09-17 from https://api.ai-analytics.org/clinical/NCT04335539. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*