Efficacy and Safety of Oral Neomycin for the Decolonization of Carbapenem-Resistant Enterobacterales: An Open-Label Randomized Controlled Trial
Abstract
:1. Introduction
2. Results
2.1. Inclusion of Participants
2.2. Baseline Characteristics of Participants
2.3. Efficacy of Neomycin for the Decolonization of CRE at Day 7 ± 2 and Day 14 ± 2
2.4. Species of CRE Isolates
2.5. Safety and Tolerability
2.6. Susceptibility Rates of CRE Isolates
3. Discussion
4. Materials and Methods
4.1. Study Design and Setting
4.2. Participants
4.3. Detection of CRE
4.4. Intervention
4.5. Follow-Up of Participants
4.6. Study Outcomes
4.7. Sample Size Estimation and Statistical Analysis
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | Neomycin Group (n = 26) | Control Group (n = 26) | p |
---|---|---|---|
Male | 8 (30.8%) | 15 (57.7%) | 0.05 |
Mean age (SD), years | 63.6 (20.9) | 71.7 (14.1) | 0.11 |
Alive at discharge from hospital | 22 (84.6%) | 17 (65.4%) | 0.11 |
Status before/on admission | |||
Underlying disease | 22 (84.6%) | 26 (100.0%) | 0.11 |
Heart disease | 4 (15.4%) | 10 (38.5%) | 0.06 |
Pulmonary disease | 2 (7.7%) | 7 (26.9%) | 0.14 |
Hypertension | 15 (57.7%) | 18 (69.2%) | 0.39 |
Diabetes mellitus | 9 (34.6%) | 10 (38.5%) | 0.77 |
Renal disease | 3 (11.5%) | 7 (26.9%) | 0.16 |
Cerebrovascular disease | 11 (42.3%) | 6 (23.1%) | 0.14 |
Gastrointestinal and liver disease | 2 (7.7%) | 2 (7.7%) | 1.00 |
Hematologic malignancy | 2 (7.7%) | 1 (3.8%) | 1.00 |
Solid malignancy | 2 (7.7%) | 4 (15.4%) | 0.67 |
Autoimmune disease | 3 (11.5%) | 1 (3.8%) | 0.61 |
Median Karnofsky performance status scale (IQR) | 50.0 (40.0–80.0) | 50.0 (40.0–60.0) | 0.32 |
Transfer from long-term care facility | 2 (7.7%) | 4 (15.4%) | 0.67 |
Previous hospitalization within 3 months | 15 (57.7%) | 13 (50.0%) | 0.58 |
Urinary catheter | 1 (3.8%) | 4 (15.4%) | 0.35 |
Nasogastric tube | 3 (11.5%) | 6 (23.1%) | 0.47 |
Tracheostomy tube | 5 (19.2%) | 5 (19.2%) | 1.00 |
Previous major surgery within 3 months | 2 (7.7%) | 1 (3.8%) | 0.55 |
Previous antibiotic use within 3 months | 15 (57.7%) | 15 (57.7%) | 1.00 |
Previous immunosuppressive agent use within 3 months | 4 (15.4%) | 4 (15.4%) | 1.00 |
Previous CRE infection | 0 (0.0%) | 1 (3.8%) | 1.00 |
Previous CRE colonization | 2 (7.7%) | 4 (15.4%) | 0.67 |
Status during admission | |||
Indwelling central intravascular line | 5 (19.2%) | 3 (11.5%) | 0.70 |
Mechanical ventilator | 13 (50.0%) | 14 (53.8%) | 0.78 |
Indwelling urinary catheter | 21 (80.0%) | 21 (80.0%) | 1.00 |
Major surgery | 5 (19.2%) | 0 (0.0%) | 0.05 |
Chemotherapy | 3 (11.5%) | 0 (0.0%) | 0.24 |
Diagnosis | |||
Heart disease | 2 (7.7%) | 4 (15.4%) | 0.67 |
Pulmonary disease | 2 (7.7%) | 6 (23.1%) | 0.25 |
Renal disease | 2 (7.7%) | 3 (11.5%) | 1.00 |
Cerebrovascular disease | 5 (19.2%) | 1 (3.8%) | 0.19 |
Hematologic malignancy | 2 (7.7%) | 1 (3.8%) | 1.00 |
Solid malignancy | 4 (15.4%) | 1 (3.8%) | 0.35 |
Autoimmune disease | 3 (11.5%) | 0 (0.0%) | 0.24 |
Previous or current documented or presumed infection during this admission up to the end of the study | 21 (80.8%) | 26 (100.0%) | 0.05 |
Had received or receiving antibiotics during this admission up to the end of the study | 26 (100.0%) | 26 (100.0%) | 1.00 |
Species of CRE isolates | 28 CRE isolates | 28 CRE isolates | |
E. coli | 8 (28.6%) | 10 (35.7%) | 0.78 |
Non-E. coli | 20 (71.4%) | 18 (61.5%) | 0.78 |
Susceptibility of neomycin against 28 CRE isolates | 26 (92.9%) | 26 (92.9%) | 1.00 |
Susceptibility of gentamicin against 28 CRE isolates | 14 (50.0%) | 13 (46.4%) | 0.80 |
Susceptibility of amikacin against 28 CRE isolates | 13 (46.4%) | 15 (53.6%) | 0.80 |
MIC50 of neomycin against 28 CRE isolates | 2 mg/L | 2 mg/L | |
MIC90 of neomycin against 28 CRE isolates | 8 mg/L | 8 mg/L | |
MIC range of neomycin against 28 CRE isolates | 1–32 mg/L | 1– > 128 mg/L |
Persistence of CRE Fecal Carriage | Neomycin Group (n = 26) | Control Group (n = 26) | p |
---|---|---|---|
Day 1 | 26 (100.0%) | 26 (100.0%) | |
Day 7 ± 2 | 12 (46.2%) | 21 (80.8%) | 0.01 |
Day 14 ± 2 | 19 (73.1%) | 16 (61.5%) | 0.56 |
21 (80.8%) | 0.74 |
Susceptibility of CRE to | Neomycin Group | Control Group | p |
---|---|---|---|
neomycin on day 1 | 26/28 (92.9%) | 26/28 (92.9%) | 1.00 |
neomycin on day 7 ± 2 | 12/14 (85.7%) | 20/22 (90.9%) | 0.64 |
neomycin on day 14 ± 2 | 18/22 (81.8%) | 15/17 (88.2%) | 0.68 |
p | 0.50 | 0.87 | |
gentamicin on day 1 | 14/28 (50.0%) | 13/28 (46.4%) | 1.00 |
gentamicin on day 7 ± 2 | 7/14 (50.0%) | 10/22 (45.4%) | 0.94 |
gentamicin on day 14 ± 2 | 12/22 (54.4%) | 9/17 (52.9%) | 0.82 |
p | 0.94 | 0.95 | |
amikacin on day 1 | 13/28 (46.4%) | 15/28 (53.6%) | 0.79 |
amikacin on day 7 ± 2 | 6/14 (42.9%) | 9/22 (40.9%) | 0.82 |
amikacin on day 14 ± 2 | 12/22 (54.5%) | 9/17 (52.9%) | 0.82 |
p | 0.76 | 0.63 |
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Tancharoen, L.; Srisomnuek, A.; Tiengrim, S.; Thamthaweechok, N.; Tangkorskul, T.; Thamlikitkul, V. Efficacy and Safety of Oral Neomycin for the Decolonization of Carbapenem-Resistant Enterobacterales: An Open-Label Randomized Controlled Trial. Antibiotics 2024, 13, 781. https://doi.org/10.3390/antibiotics13080781
Tancharoen L, Srisomnuek A, Tiengrim S, Thamthaweechok N, Tangkorskul T, Thamlikitkul V. Efficacy and Safety of Oral Neomycin for the Decolonization of Carbapenem-Resistant Enterobacterales: An Open-Label Randomized Controlled Trial. Antibiotics. 2024; 13(8):781. https://doi.org/10.3390/antibiotics13080781
Chicago/Turabian StyleTancharoen, Lalita, Ananya Srisomnuek, Surapee Tiengrim, Narisara Thamthaweechok, Teerawit Tangkorskul, and Visanu Thamlikitkul. 2024. "Efficacy and Safety of Oral Neomycin for the Decolonization of Carbapenem-Resistant Enterobacterales: An Open-Label Randomized Controlled Trial" Antibiotics 13, no. 8: 781. https://doi.org/10.3390/antibiotics13080781