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Switch to Oral Antibiotics in Gram-negative Bacteremia

NCT04146922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2023-08-14

No results posted yet for this study

Summary

Eligible subjects will be those age 18 years or more with mono-microbial blood stream infection caused by E. coli, Klebsiella species, Enterobacter species, Serratia species, Citrobacter species, or Proteus species, who have achieved adequate source control, are afebrile and hemodynamically stable for 48 hours or more and have received microbiologically active intravenous therapy for 3-5 days. The bloodstream isolate must be susceptible to amoxicillin, amoxicillin-clavulanate, fluoroquinolones, oral cephalosporins and/or trimethoprim-sulfamethoxazole and the subject must be able to take oral medication directly or through a feeding tube. Exclusions criteria include allergy to all in-vitro active antimicrobials which are available in oral formulations, pregnancy, infective endocarditis, central nervous system infection, terminal illness with expected survival less than 14 days, absolute neutrophil count less than 1,000/ml and hematopoietic or solid organ transplantation within the preceding 90 days. Randomization will be stratified by urinary versus non-urinary source of bacteremia. The primary outcome is treatment failure at 90-days with 10% margin for non-inferiority in the 95% confidence interval around the difference in outcome between the two study groups.

Conditions

  • Escherichia Coli Bacteremia
  • Klebsiella Bacteraemia
  • Enterobacter Bacteraemia
  • Serratia Bacteraemia
  • Citrobacter Bacteraemia
  • Proteus Bacteraemia

Interventions

OTHER

Step down to oral antimicrobial therapy

Step down from intravenous to oral antimicrobial therapy to complete the intended course of treatment.

OTHER

IV antimicrobial therapy

No step down from intravenous to oral antimicrobial therapy to complete the intended course of treatment.

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Ali S Omrani, FRCP FRCPath · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-13
Primary Completion
2022-08-30
Completion
2023-07-30

Countries

  • Bahrain
  • Kuwait
  • Qatar
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04146922 on ClinicalTrials.gov