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MULTI-CENTER RANDOMIZED STUDY CONTROLLED WITH DOUBLE-BLIND PLACEBO OF 3 ARMS OF PHASE 3 TO EVALUATE THE SAFETY AND EFFICACY OF THE ADMINISTRATION OF TIFACOGIN (RECOMBINANT INHIBITOR OF THE TISSUE FACTOR´S ROUTE) IN SUBJECTS WITH PNEUMONIA ACQUIRED IN THE SEVERE COMMUNITY

MULTI-CENTER RANDOMIZED STUDY CONTROLLED WITH DOUBLE-BLIND PLACEBO OF 3 ARMS OF PHASE 3 TO EVALUATE THE SAFETY AND EFFICACY OF THE ADMINISTRATION OF TIFACOGIN (RECOMBINANT INHIBITOR OF THE TISSUE FACTOR´S ROUTE) IN SUBJECTS WITH PNEUMONIA ACQUIRED IN THE SEVERE COMMUNITY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-047-04
Enrollment
19
Registered
2004-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

Tifacogin 0.025 mg / kg / hour Type of group
Tifacogin 0.025 mg / kg / hour is administered as a continuous intravenous infusion during the 96-hour dosing period. Group name:placebo Type of group
Tifacogin placebo is administered as a continuous intravenous infusion during the 96-hour dosing period.

Sponsors

NOVARTIS BIOSCIENSES PERU S.A., CONSULTORES EN INFECTOLOGIA S.A.C.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults from 18 years of age. 2. Clinical diagnosis of community-acquired pneumonia supported by the following evidence (clinical signs, radiographic findings and microbiological results). 3. Pneumonia of sufficient severity to require admission and management in ICU and that meets one of the criteria of major severity or two of the minors. 4. Ability to start treatment within 36 hours after admission to the ICU and within 72 hours after hospitalization. 5. Informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnancy (confirmed by urine or serum test). 2. Weight> 150 kg. 3. Hospitalization within 14 days prior to the current hospitalization. 4. Non-ambulatory resident of a long-term care institution. 5. Requires long-term mechanical ventilation. 6. Confirmation or suspicion of aspiration pneumonitis. 7. Post-obstructive pneumonia

Design outcomes

Primary

MeasureTime frame
Outcome name:Mortality from all causes with community-acquired pneumonia Measure:To compare the effect of tifacogin versus placebo on all-cause mortality at 28 days in subjects with severe community-acquired pneumonia (CAP). Timepoints:28 days—

Secondary

MeasureTime frame
Outcome name:Mortality from all causes with pneumonia Measure:Effect of the administration of tifacogin on the incidence of treatment failures. Timepoints:28 days—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)