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Open-label randomized comparative study of cefepime vs. meropenem in adults with moderate to severe aspiration pneumonia

Open-label randomized comparative study of cefepime vs. meropenem in adults with moderate to severe aspiration pneumonia - Cefepime vs. meropenem in moderate to severe aspiration pneumonia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001349
Enrollment
120
Registered
2008-09-30
Start date
2008-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration pneumonia

Interventions

cefepime 1g dose parenteral infusion, every 8 hrs, for 4-14 days. May be adjusted when renal failure. Erythromycin 500mg parenteral infusion every 12 hrs, or Azithromycin 500mg parenteral infusion e

Sponsors

Ono Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Hospital-admitted patients aged 15 yrs or more with a diagnosis of moderate to severe pneumonia and required initial parenteral treatment. (2)At least one of the following conditions of risk for aspiration pneumonia: neurological disorders (cerebrovascular diseases, neuromuscular diseases, dementia, etc.), bed-ridden, oral/pharyngeal/laryngeal disorder, gastro-esophageal disorder (esophageal diverticulum, achalasia, systemic sclerosis, esophageal cancer, GERD, post-gastrectomy (total or partial), hiatal hernia, etc.), usage of sedatives or hypnotics, insertion of a nasogastric tube, subjective or observed aspiration/choking/dysphagia, episode of vomiting. (3)Radiological appearance of a new and/or progressive pulmonary infiltrate(s) (4) At least two of the followings: cough, sputum or change of sputum character (increased volume and/or purulence), dyspnea, tachypnea, abnormal breathing sound (wheeze etc.), pleuritic chest pain, auscultatory findings on chest examination consistent with the lung infiltrate, documented body temperature > or = 37.5C within the past 24hrs, rigors and/or chills, general malaise, and a WBC count of > or = 10,000/mm3 or < 3,000/mm3.

Exclusion criteria

Exclusion criteria: (1) Hospital-acquired pneumonia (2) Hospitalization within 60 days prior to the development of the symptom(s) (3) Immunocompromising disease or receipt of immunopompromising therapy (4) Active lung cancer (5) Terminal illness (6) Pregnancy or breast-feeding (7) Known allergy to the indicated antibiotics (8) Other infiltrative diseases (e.g. radiation pneumonitis, organizing pneumonia, drug-induced pneumonia, obstructive pneumonia etc.) (9) Tuberculosis, fungal infection (10) Empyema

Design outcomes

Primary

MeasureTime frame
Clinical response at the end of therapy, days 11-14

Secondary

MeasureTime frame
Early clinical response at days 4 and 7 Bacteriological response at days 11-14 (in bacteriologically evaluable patients) Survival at day 30

Countries

Japan

Contacts

Public ContactSeizo Kadowaki

Ono Municipal Hospital Department of Internal Medicine

0794-63-2020

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026