Clinical Trials Logo
  1. Home
  2. Community-Acquired Pneumonia
  3. NCT04071041

Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia. — ALBUCAP  

Community-acquired Pneumonia Clinical Trial

Official title:
Effect of Albumin Administration on Outcomes in Hypoalbuminemic Patients Hospitalized With Community-acquired Pneumonia (ALBUCAP): a Prospective, Randomized, Phase III Clinical Controlled Trial.

Clinical Trial Summary

Community-acquired pneumonia (CAP) remains a leading cause of death world-wide. Hypoalbuminemia is associated with worse outcomes. However, whether albumin administration would have a beneficial effect in outcome in patients with CAP remains uncertain. This project proposes to test the hypothesis of whether the administration of albumin in hypoalbuminemic patients with CAP would increase the proportion of clinical stable patients at day 5.

Clinical Trial Description

This project will consist of a superiority, non-blinded, multicentre, randomized, phase 3, interventional controlled clinical trial. The estimated sample size is of 360 patients, who will be recruited from three Spanish hospitals. Hypoalbuminemic (≤30g/L) adult patients with CAP will be randomly assigned (1:1) to receive standard care plus albumin (20g in 100ml) every 12 hours for 4 days or standard care alone. The primary endpoint will be the proportion of clinical stable patients at day 5, defined as stable vital signs for at least 24h, analyzed by intention to treat. The secondary endpoints will be time to clinical stability; duration of intravenous and total antibiotic treatment; length of hospital stay; intensive care unit admission; duration of mechanical ventilation and vasopressor treatment; adverse events; readmission within 30 days and all-cause mortality. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04071041
Study type Interventional
Source Hospital Universitari de Bellvitge
Contact
Status Terminated
Phase Phase 3
Start date October 31, 2019
Completion date October 31, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05722938 - Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) Phase 3
Terminated NCT04972318 - Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia N/A
Recruiting NCT06065618 - Characteristics of Hospitalized Patients With Community-acquired Pneumonia
Not yet recruiting NCT03675178 - Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia Phase 4
Not yet recruiting NCT04166110 - Antibiotic Therapy In Respiratory Tract Infections N/A
Completed NCT02380352 - Short-course Antimicrobial Therapy for Paediatric Respiratory Infections Phase 4
Completed NCT01671280 - Drug Use Investigation Of Azithromycin IV For Community-Acquired Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan) N/A
Completed NCT02555852 - Proton Pump Inhibitors and Risk of Community-acquired Pneumonia N/A
Recruiting NCT00752947 - Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors Phase 4
Completed NCT00140023 - Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia Phase 3
Recruiting NCT04089787 - Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia Phase 4
Completed NCT05356494 - Postural Drainage and PEP Technique in Community Acquired Pneumonia N/A
Completed NCT05133752 - Oral Nemonoxacin in Treating Elderly Patients With CAP Phase 4
Not yet recruiting NCT06291012 - Stopping Pneumonia Antibiotherapy Regimen Early Phase 4
Recruiting NCT05002192 - A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
Completed NCT03452826 - Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia N/A
Completed NCT03474991 - KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP Phase 3
Withdrawn NCT01662258 - Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP N/A
Completed NCT01723644 - Clinical Reassessment Versus Procalcitonin in Order to Shorten Antibiotic Duration in Community-acquired Pneumonia N/A
Completed NCT01683487 - Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Phase 4