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Open-label randomized comparative study of cefotiam vs. ampicillin/sulbactam in adults with mild to moderate community-acquired pneumonia

Open-label randomized comparative study of cefotiam vs. ampicillin/sulbactam in adults with mild to moderate community-acquired pneumonia - Comparative study of cefotiam vs. ampicillin/sulbactam in adult community-acquired pneumonia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001351
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

Community-acquired pneumonia

Interventions

cefotiam 1g IV, every 12 hrs, for 4-14 days. Clarithromycin 200mg PO, bid, for 4-14 days. May be adjusted when renal failure. ampicillin/sulbactam 3g IV, every 12 hrs, for 4-14 days. Clarithrom

Sponsors

Ono Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with community-acquired pneumonia aged 15 yrs or more (2) Radiological appearance of a new and/or progressive pulmonary infiltrate(s) (3) 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 axillary 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 (11) Aspiration pneumonia

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