Analysis of antibiotic resistant infections associated with hirudotherapy
Brauer PR, Saadah M, Fritz MA, Wu SS, Lamarre ED (2024) · American Journal of Otolaryngology · n=19
Study Profile
- Design
- retrospective cohort analysis of all hirudotherapy-related adverse events (FDA product code NRN) reported to the FDA MAUDE database from 2012-2021 (Cleveland Clinic Head and Neck Institute + Case Western Reserve, USA)
- Sample size (n)
- 19
- Intervention
- Whole-leech medicinal leech therapy in patients reported to MAUDE for adverse events involving antibiotic resistance (any organism, any clinical setting)
- Comparator
- Not applicable — descriptive cohort with no comparator arm
- Primary endpoint
- Incidence and microbiology of antibiotic-resistant infections after hirudotherapy
- Primary result
- 19 cases of antibiotic-resistant hirudotherapy infections identified; 16/19 (84.2%) associated with patient injury; positive cultures or fever in 26.3%; Aeromonas hydrophila most common (13/19, 68.4%), followed by Vibrio vulnificus (3/19), Pseudomonas aeruginosa (2/19), Proteus vulgaris (1/19); 9/19 (47.4%) multi-drug resistant; resistance documented to fluoroquinolones (47.4%), TMP-SMX (47.4%), and ertapenem (21.1% — a drug of last resort)
- Follow-up duration
- 10-year MAUDE reporting window (2012-2021)
- PMID
- 39208707
Key Findings
- 19 MAUDE reports of antibiotic-resistant infections after hirudotherapy (2012-2021)
- Aeromonas hydrophila accounts for 68.4% — consistent with the established leech-gut symbiont profile
- Vibrio vulnificus (15.8%) emerges as a new concern requiring different prophylactic coverage than ciprofloxacin
- 47.4% multi-drug resistance and 21.1% ertapenem resistance represent escalating stewardship pressure
- Findings support shift toward culture-directed therapy and avoidance of empiric fluoroquinolone monotherapy
Limitations
- MAUDE is a voluntary passive surveillance database — significant underreporting likely
- No denominator data (total hirudotherapy procedures performed) — cannot estimate incidence
- No standardized infection definitions across reports
- Some reports lacked complete antibiogram data
- Single-decade window may miss emerging-resistance trends from earlier hirudotherapy
Clinical Implications
Brauer 2024 is now the largest US dataset documenting antibiotic-resistant infection trends in hirudotherapy and directly informs ASH stewardship guidance. For US clinicians using leech therapy under K040187, the data argue for (1) culture-directed antibiotic selection rather than reflexive ciprofloxacin monotherapy, (2) coverage that anticipates Vibrio vulnificus in maritime exposure or coastal patient populations, and (3) early infectious-disease consultation when MDR organisms are isolated. The findings also support continued investment in pharmacologic-leeching alternatives (Harun 2018 bivalirudin) for patients at high MDR risk.
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