Status:
TERMINATED
Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections
Lead Sponsor:
Hospital Moinhos de Vento
Conditions:
Carbapenem-Resistant Enterobacteriaceae Infection
Bloodstream Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Antimicrobial resistance is a major global problem, particularly in hospital-acquired infections (HAIs). Gram-negative bacilli (GNB), including Enterobacterales, Pseudomonas aeruginosa, and Acinetobac...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Infection's diagnosis while in the ICU
- Severe infection in any site (defined as the presence of sepsis/septic shock or bloodstream infection or pneumonia) associated with a positive culture by MRD-GNB (Acinetobacter baumannii complex, Pseudomonas aeruginosa, and Enterobacterales bacteria, only susceptible to carbapenems and/or polymyxins)
- Hemodynamically stable and afebrile (axillary temperature less than 37.8ºC) for at least 48 hours on day 7 of adequate antibiotic therapy
- Consent of the team providing care to the patient regarding their inclusion in the research
- Exclusion criteria
- Inclusion in other experimental studies involving antimicrobial therapy
- Infections that have as the primary site: endocarditis/endovascular infection, necrotizing fasciitis, osteomyelitis, abdominal abscess or other abdominal infections requiring surgical intervention (except infections that have been treated surgically, with curative character within the first 3 days of appropriate antimicrobial therapy), central nervous system Infections, empyema, prosthetic infection;
- Immunosuppression defined as: neutrophil cells \<1000/mm³ in the current hospitalization, HIV/AIDS diagnosis with last CD4 count \<200/mm³, solid organ transplantation in the last year and/or need for increased immunosuppression due to acute rejection in the last year, hematopoietic stem cell transplantation in the last year, and/or current therapy for chronic graft-versus-host disease
- Positive blood cultures for the same pathogen within 48 hours prior to randomization, when collected
- Uncontrolled concomitant infection with another GNB (regardless of susceptibility profile)
- Previous inclusion in this study
- Known pregnancy
- Patient in palliative care who has already decided not to restart antimicrobials, if necessary, or hemodynamic support measures.
Exclusion
Key Trial Info
Start Date :
January 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT05210387
Start Date
January 27 2022
End Date
December 31 2023
Last Update
March 6 2024
Active Locations (29)
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1
Hospital OTO clinica
Fortaleza, Ceará, Brazil
2
Hospital Evangélico de Vila Velha
Vila Velha, Espírito Santo, Brazil, 29118-060
3
Hospital Cleriston de Andrade
Feira de Santana, Estado de Bahia, Brazil, 44089-340
4
Hospital Couto Maia
Salvador, Estado de Bahia, Brazil