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Trial record 13 of 15848 for:    Anti-Bacterial

Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia (MULTI-CAP)

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ClinicalTrials.gov Identifier: NCT03452826
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

To assess the effectiveness of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin (intervention) in severe CAP, as compared to a conventional strategy (control).

A multicentre, parallel-group, open-label, randomized controlled trial. The primary assessment criterion est the number of antibiotic-free days at 28 days


Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Device: Antibiotic therapy according to the result of mPCR (device) Not Applicable

Detailed Description:

Randomization is performed immediately after the inclusion.

  • In the intervention arm, a broad panel respiratory mPCR is performed on a lower respiratory tract sample (bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum), collected before the 12th hour following inclusion.
  • In both arms, an additional lower respiratory tract sample (bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum) is collected for biological studies and banking.
  • In the intervention arm, an algorithm of early antibiotic de-escalation and discontinuation is based on the early microbiological results, including the mPCR results, and the procalcitonin value. This algorithm is applied as soon as possible (before the 24th hour following inclusion if possible).
  • In the control arm, initial antibiotic therapy is maintained, according to guidelines.
  • In both arms, after 72 hours of antibiotic therapy, ICU physicians are advised to use procalcitonin (values and kinetics) to guide antibiotic therapy discontinuation, with a recommended total duration of 7 days, unless otherwise indicated.
  • In both arms, a switch to oral therapy is encouraged

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Combined Use of a Respiratory Broad Panel MULTIplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia: a Multicentre, Parallel-group, Open-label, Randomized Controlled Trial.
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antibiotic therapy according to the result of mPCR
Combined use of a respiratory broad panel Multiplex polymerase chain reaction (mPCR) (performed on a lower respiratory tract sample : bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum) and procalcitonin.
Device: Antibiotic therapy according to the result of mPCR (device)
  • Phone call at D28 and D90, unless the patient is still hospitalized;
  • Collection of a respiratory tract sample (either distal, i.e. tracheal aspirate or bronchoalveolar lavage, or proximal, i.e. sputum) for broad panel respiratory mPCR in the intervention arm.
  • Collection of an additional respiratory tract sample for biological banking in both arms.
Other Name: Antibiotic therapy to be adapted according to the result of mPCR (device)

No Intervention: Antibiotic therapy at discretion of ICU physicians
Antibiotic therapy at discretion of ICU physicians



Primary Outcome Measures :
  1. The effectiveness of a management combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin in severe CAP, as compared to a conventional strategy [ Time Frame: Day 28 ]
    the number of antibiotic free days at D28, which corresponds to the number of days alive without any at Day 28.


Secondary Outcome Measures :
  1. Mortality at 28 (D28) and 90 days (D90); [ Time Frame: Day 28 and day 90 ]
    Mortality rate at D28 and D90

  2. Number of defined daily dose (DDD) per 100 patient days of broad- and narrow-spectrum antibiotics [ Time Frame: Day 28 ]
    Number of defined daily dose (DDD) per 100 patient days of broad- and narrow-spectrum antibiotics

  3. Antibiotics duration at D28 [ Time Frame: Day 28 ]
    Antibiotics duration at D28

  4. Number of organ-failure free days (based on SOFA) at D28 [ Time Frame: Day 28 ]
    Number of organ-failure free days (based on SOFA) at D28

  5. Incidence rates of bacterial superinfections at D28 [ Time Frame: Day 28 ]
    Incidence rates of bacterial superinfections at D28

  6. Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28 [ Time Frame: Day 28 ]
    Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28

  7. Incidence rates of relapse (same pathogen) or reinfection (another pathogen) at D28 [ Time Frame: Day 28 ]
    Incidence rates of relapse (same pathogen) or reinfection (another pathogen) at D28

  8. Duration of ICU and hospital stay [ Time Frame: Day 90 ]
    Duration of ICU and hospital stay

  9. Cost of the total hospital admissions (including 90-day repeated admissions), ICU costs, cost of the microbiological diagnostic workup; [ Time Frame: Day 90 ]
    Cost of the total hospital admissions (including 90-day repeated admissions), ICU costs, cost of the microbiological diagnostic workup;

  10. Incremental / decremental cost effectiveness ratio in cost per treatment success (90-day composite of all-cause death and infection recurrence). [ Time Frame: Day 90 ]
    Incremental / decremental cost effectiveness ratio in cost per treatment success (90-day composite of all-cause death and infection recurrence).

  11. Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference [ Time Frame: Day 28 ]
    Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference

  12. Euroquol questionary (EQ-5D-3L) [ Time Frame: Day 90 ]
    Euroquol questionary (EQ-5D-3L)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (≥18 years) with CAP admitted to the ICU since 18 hours or less; the diagnosis of pneumonia includes two clinical criteria among a temperature > 37.8°C, tachypnea (respiratory rate > 25/min), chest pain, cough, expectoration, localized crackles, with or without signs of pleural effusion, pulse oximetry less than 92% while breathing room air, and a newly-appeared parenchymal infiltrate; the pneumonia is community-acquired if the time between hospital admission and ICU referral is below or equal to 48 hours.
  • Informed consent or emergency procedure.

Exclusion Criteria:

  • Pregnancy;
  • Congenital immunodeficiency;
  • HIV infection with the lymphocyte CD4 count below 200/mm3 or unknown in the last year;
  • Acute hematologic malignancy;
  • Neutropenia (<1 leucocyte/mL or < 0.5 neutrophil/mL);
  • Immunosuppressive drugs within the previous 30 days, including anti-cancer chemotherapy and anti-rejection drugs for organ/bone marrow transplant
  • Corticosteroids ≥ 20 mg/d of prednisone equivalent for more than 14 days;
  • chronic obstructive pulmonary disease (COPD) with previous history of colonization/infection with Pseudomonas aeruginosa;
  • Tracheostomy;
  • Diffuse bronchiectasis, cystic fibrosis;
  • Aspiration pneumonia;
  • Moribund patient or death expected from underlying disease during the current admission;
  • Patient deprived of liberty or under legal protection measure;
  • Participation in another interventional trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452826


Contacts
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Contact: Jean-François TIMSIT, PU-PH 0140257702 jean-francois.timsit@aphp.fr
Contact: Muriel FARTOUKH, PU-PH 01 56 01 65 72 muriel.fartoukh@aphp.fr

Locations
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France
Hôpital BICHAT Recruiting
Paris, France, 75018
Contact: Jean-François TIMSIT, PU-PH    01 40 25 77 02    jean-francois.timsit@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-François TIMSIT, PU-PH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03452826     History of Changes
Other Study ID Numbers: P160928J
AO 1615-48 ( Other Grant/Funding Number: PHRC )
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents