An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT04215991

Title field or adapter rule

protocolSection.identificationModule.officialTitle

Ingested At

2026-04-25T22:27:46.352645+00:00

Published At

2025-05-25T00:00:00+00:00

Record Updated At

2025-05-25

Timestamp Basis

source retrieval time was not retained by the feed adapter

Date limitation

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Fields recorded by this source

protocolSection.conditionsModule.conditions

["Gram-negative Bacterial Infections", "Hospital Acquired Bacterial Pneumonia (HABP)", "Complicated Urinary Tract Infection (cUTI)", "Ventilator Associated Bacterial Pneumonia (VABP)"]

protocolSection.statusModule.lastUpdatePostDateStruct.date

"2025-05-25"

protocolSection.identificationModule.nctId

"NCT04215991"

protocolSection.identificationModule.officialTitle

"An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to \u003c 18 Years of Age"

protocolSection.statusModule.overallStatus

"COMPLETED"

protocolSection.designModule.phases

["PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct.date

""

Study condition terms

• Gram-negative Bacterial Infections (protocolSection.conditionsModule.conditions)
• Hospital Acquired Bacterial Pneumonia (HABP) (protocolSection.conditionsModule.conditions)
• Complicated Urinary Tract Infection (cUTI) (protocolSection.conditionsModule.conditions)
• Ventilator Associated Bacterial Pneumonia (VABP) (protocolSection.conditionsModule.conditions)

Intervention details are not present in the imported fields for this record. No drug-condition relationship is inferred from co-listing.

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