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The efficacy and safety of omadine in the treatment of severe hospital-acquired pneumonia in elderly patients with liver dysfunction

The efficacy and safety of omadine in the treatment of severe hospital-acquired pneumonia in elderly patients with liver dysfunction

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128848
Enrollment
Unknown
Registered
2026-07-27
Start date
2026-04-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Healthcare-associated pneumonia

Interventions

Oxacillin group:No
Other tetracycline groups:No
Non-tetracycline standard protocol group (control group):No

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age: >= 60 years old. 2. Hospital-acquired pneumonia (HAP) as defined in the IDSA/ATS 2016 guidelines meets the diagnosis of severe pneumonia and is clinically assessed as suitable for the use of tetracycline drugs. And the suspected or confirmed target pathogen is a multi-drug resistant Gram-negative bacillus (such as Acinetobacter baumannii, ESBL enzyme-producing Klebsiella pneumoniae, etc. Drug sensitivity suggests sensitivity to tetracycline antibiotics such as tigecycline). The patient fell ill more than 48 hours after admission. 4. New or progressive pulmonary infiltration images appear on imaging. Accompanied by fever, purulent discharge or abnormal white blood cells. 5. Liver function classification: Baseline assessment meets Child-Pugh grade A (mild) or grade B (moderate).

Exclusion criteria

Exclusion criteria: 1. Severe liver failure: Child-Pugh grade C (>10 points) or acute fulminant liver failure. 2. Near-death state: The expected survival period is less than 48 hours or a refusal to rescue (DNR) has been signed, and at least 72 hours of observation cannot be completed. 3. Specific contraindications: Severe allergy to tetracycline drugs. 4. Severe complications: (1) Active pulmonary tuberculosis, pulmonary mycosis (such as invasive aspergillosis). (2) Severe coagulation disorders of non-hepatic origin (such as hemophilia, active DIC and uncorrectable).

Design outcomes

Primary

MeasureTime frame
Clinical cure rate;Deteriorated liver function/drug-induced liver injury (DILI);

Secondary

MeasureTime frame
The length of stay in the ICU;The number of days without a ventilator after enrollment;Death due to any cause within 28 days after enrollment;The incidence of septic shock within 21 days after enrollment;The change in SOFA score on the day of enrollment and at the evaluation time point;Adverse events in the blood system, gastrointestinal tract, skin, cardiovascular system, nervous system, etc;

Countries

China

Contacts

Public ContactJiang Wenqiang

Guangdong Provincial People's Hospital

jiangwenqiang@gdph.org.cn+86 137 5179 1365

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026