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CUSTOMIZED ANTIBIOTIC TREATMENT DURATION AMONG HOSPITALIZED PATIENTS WITH MODERATELY SEVERE COMMUNITY-ACQUIRED PNEUMONIA [CAT-CAP]

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504208-27-00
Acronym
APHP220814
Enrollment
424
Registered
2023-12-15
Start date
2024-02-12
Completion date
Unknown
Last updated
2025-04-10

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

Conditions

Community-acquired pneumonia

Brief summary

Rate of cure at Day 15 after treatment initiation Cure at Day 15 will be defined by the association of: 1.Persistence of stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure > 90mmHg; oxygen saturation ≥ 92%; respiratory rate < 24/min; normal mental status); 2.No additional antibiotic treatment, targeting CAP, taken after the end of initial antibiotic treatment. Patients dead or not cured as defined above, will be classified as failure at Day 15.

Detailed description

Rate of cure at Day 30 after the start of treatment defined by the association of: persistence of stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure > 90mmHg; O2 saturation ≥ 90% on room air; respiratory rate < 24/min; normal mental status); absence of additional antibiotic treatment needed after the end of initial antibiotic treatment ((except for oral fosfomycin, furadantin and pivmecillinam)., All-cause mortality on Day 30 after the start of antibiotic treatmen, Patients' evolution of pneumonia symptoms and quality of life (CAP Score / CAP Sym) at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7, at Day 15, and at Day 30 of antibiotic treatment;, Duration of antibiotic treatment targeting CAP during the 30 days after the start of treatment;, Duration of antibiotic treatment for all indications during the 30 days after the start of treatment, Length of initial hospital stay, Frequency and severity of adverse events during the 30 days after the start of treatment., Analysis of microbiome and resistance genes at Day S and Day 30

Interventions

DRUGAMOXICILLIN
DRUGCEFTRIAXONE
DRUGLEVOFLOXACIN
DRUGCEFOTAXIME PANPHARMA 1 g
DRUG-

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Rate of cure at Day 15 after treatment initiation Cure at Day 15 will be defined by the association of: 1.Persistence of stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure > 90mmHg; oxygen saturation ≥ 92%; respiratory rate < 24/min; normal mental status); 2.No additional antibiotic treatment, targeting CAP, taken after the end of initial antibiotic treatment. Patients dead or not cured as defined above, will be classified as failure at Day 15.

Secondary

MeasureTime frame
Rate of cure at Day 30 after the start of treatment defined by the association of: persistence of stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure > 90mmHg; O2 saturation ≥ 90% on room air; respiratory rate < 24/min; normal mental status); absence of additional antibiotic treatment needed after the end of initial antibiotic treatment ((except for oral fosfomycin, furadantin and pivmecillinam)., All-cause mortality on Day 30 after the start of antibiotic treatmen, Patients' evolution of pneumonia symptoms and quality of life (CAP Score / CAP Sym) at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7, at Day 15, and at Day 30 of antibiotic treatment;, Duration of antibiotic treatment targeting CAP during the 30 days after the start of treatment;, Duration of antibiotic treatment for all indications during the 30 days after the start of treatment, Length of initial hospital stay, Frequency and severity of adverse events during

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026