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Randomized Controlled multi-center Trial for Nursing and Health care associated pneumonia with SBT/ABPC, TAZ/PIPC and DRPM

Randomized Controlled multi-center Trial for Nursing and Health care associated pneumonia with SBT/ABPC, TAZ/PIPC and DRPM - Niigata HCAP study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003896
Enrollment
510
Registered
2010-07-15
Start date
2010-08-01
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

healthcare-associated pneumonia

Interventions

SBT/ABPC group TAZ/PIPC group DRPM group

Sponsors

Niigata University Medical & Dental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have at least one of the following backgrounds (i) to (iv), and meet the following (1) to (3): (i) A history of hospitalization within 90 days prior to the onset of pneumonia (ii) Transferred from nursing-care facilities (including those who use psychiatric ward) (iii) Aged patients who need a nursing service(iv)Outpatients who continuously need a intravenus drug therapy (anti-biotics, anti-cancer drug, immunosuprressive drug etc.) (1) Patients with A-DROP moderate bacterial pneumonia (2)Patients who are deemed to be evaluable by a physician in charge (3) Hospitalized patients who are able to submit informed consent and are willing to participate in the study (Informed consent could be acquired from representative)

Exclusion criteria

Exclusion criteria: Apparent massive aspiration (chemical pneumonia due to gastric acid is assumed) Patients with a history of allergy to the study drug or past history of adverse reactions Patients with serious hepatic or renal dysfunction Hepatic dysfunction with AST and ALT elevation at least twice the institutional standard For renal dysfunction at least CKD stage 4 (Japanese Society of Nephrology CKD guideline 2009) Patients with a past history of epilepsy, or those who have central nervous system disease with convulsions at the start of the study Pregnant women, women who are possibly be pregnant, and nursing women Patients with a causative agent not sensitive to the study drug and have been found to be with infection due to strains that are apparently considered not to be sensitive (MRSA, S.maltophilia, legionella group, etc.) Patients who require coadministration of prohibited concomitant drugs Patients with lung cancer who are with apparent causation of airway obstruction

Design outcomes

Primary

MeasureTime frame
To compare the clinical efficacy among 3 treatment groups at the end of treatment.

Secondary

MeasureTime frame
1. Life prognosis at 30 days after completion of treatment 2. Ratio of drug-resistant strain of bacteria involvement in HCAP 3. Duration of hospitalization 4. Costs required for antibacterial agents administered until pneumonia was resolved

Countries

Japan

Contacts

Public ContactYoshinari TANABE

Niigata University Medical & Dental Hospital Division of Infection Control and Prevention

y-tanabe@med.niigata-u.ac.jp+81-25-227-2200

Outcome results

None listed

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