Meropenem

證據等級: L5

預測適應症: 10 個

Meropenem: From Broad-Spectrum Antibacterial Therapy to Bacterial Arthritis

One-Sentence Summary

Meropenem is a broad-spectrum carbapenem antibiotic that inhibits bacterial cell-wall synthesis; the evidence pack does not contain a specific approved-indication record for it (the drug is not currently marketed in Taiwan). The TxGNN model predicts it may be effective for Bacterial Arthritis (septic arthritis), with 1 indirectly-related clinical trial and 20 publications — mostly case reports and retrospective series on melioidosis/ESBL-related septic arthritis — currently supporting this direction.

Quick Overview

Item	Content
Original Indication	Not available in this evidence pack — meropenem is not marketed in Taiwan (0 licenses on file), so no approved-indication text exists to cite
Predicted New Indication	Bacterial Arthritis
TxGNN Prediction Score	99.92%
Evidence Level	L3
Taiwan Market Status	✗ Not Marketed (未上市)
Number of TFDA Licenses	0
Recommended Decision	Proceed with Guardrails

Why is This Prediction Reasonable?

Detailed mechanism-of-action data was not returned from DrugBank in this evidence pack (flagged as data gap DG002). Based on the mechanistic rationale accompanying this prediction, meropenem is a broad-spectrum carbapenem that inhibits bacterial penicillin-binding proteins (PBPs), blocking peptidoglycan cell-wall synthesis. This gives it activity against many of the Gram-positive and Gram-negative organisms that commonly cause septic (bacterial) arthritis — including MSSA, Enterobacterales, and Burkholderia pseudomallei (melioidosis).

Because no confirmed original indication is on record here, similarity between “original” and “new” indication cannot be formally assessed. However, carbapenems as a class are well established in infectious-disease practice as empirical or targeted therapy for multidrug-resistant or mixed infections, including bone-and-joint infections. The literature evidence below reflects real-world use of meropenem in septic arthritis and osteoarticular infection (notably melioidosis-related and ESBL-producing-pathogen cases), which supports mechanistic plausibility even though it does not constitute a formal approved indication.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT01371656	Phase 3	Completed	624	Trial of levofloxacin (not meropenem) to prevent bacteremia in children with acute leukemia/HSCT. Different drug and different indication from bacterial arthritis — only indirectly relevant (relevance grade C).

Literature Evidence

PMID	Year	Type	Journal	Key Findings
17433752	2007	Case report	Joint Bone Spine	Septic arthritis due to ESBL-producing Klebsiella pneumoniae successfully treated with meropenem plus amikacin combined with early arthroscopic washout
35146367	2021	Retrospective cohort	Le Infezioni in Medicina	Cohort of osteoarticular melioidosis characterizing bone/joint involvement; isolates assessed for carbapenem susceptibility
39489417	2024	Retrospective review	Indian J Med Microbiol	22 cases of musculoskeletal melioidosis (osteomyelitis and septic arthritis); all isolates susceptible to meropenem
39380073	2024	Case report	J Med Case Rep	Disseminated melioidosis presenting with septic arthritis, initially misdiagnosed as tuberculosis, illustrating a challenge to routine antibiotic therapy
38139869	2023	Case report	Pharmaceuticals (Basel)	Native hip septic arthritis caused by Bacillus pumilus/Paenibacillus barengoltzii, managed with long-term linezolid (relevant comparator case)
39288382	2024	Case report + systematic review	J Infect Dev Ctries	Leptospirosis–melioidosis coinfection presenting as ARDS and osteomyelitis
39193962	2024	Retrospective study	Clinical Laboratory	Pathogen distribution and antimicrobial resistance analysis in bone-and-joint infections among young children
37713001	2024	Retrospective/antibiogram study	Eur J Orthop Surg Traumatol	Antibiogram development for empiric antibiotic strategy in non-spinal orthopaedic infections, including septic arthritis
31319190	2019	Preclinical (animal model)	Int J Antimicrob Agents	Colistin-containing cement spacer for carbapenemase-producing K. pneumoniae prosthetic joint infection in a rabbit model
33857030	2021	In vitro study	J Bone Joint Surg Am	Thermal stability and elution kinetics of meropenem and other alternative antibiotics in PMMA bone cement for orthopaedic infection treatment

Taiwan Market Information

Meropenem currently holds no TFDA marketing license in Taiwan (0 licenses on file; market status: 未上市 / Not Marketed). No product name, dosage form, or approved-indication text is available to report.

Safety Considerations

Please refer to the package insert for safety information. (Key warnings, contraindications, and drug interaction data were all flagged as data gaps in this evidence pack — data gap DG001, severity Blocking.)

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: Evidence level L3 is supported by multiple retrospective series and case reports of meropenem used in septic/osteoarticular infections (notably melioidosis-related and ESBL-producing-pathogen septic arthritis), but there is no direct RCT evidence specific to bacterial arthritis and only one indirectly related clinical trial. Critically, TFDA safety data (warnings/contraindications) is a Blocking-severity data gap, so a formal S1 safety assessment cannot yet proceed.

To proceed, the following is needed:

TFDA package insert (warnings/contraindications) — currently Blocking (DG001); required before any safety evaluation
Confirmed mechanism-of-action data via DrugBank API — currently High priority gap (DG002)
Direct comparative or interventional evidence for meropenem specifically in bacterial/septic arthritis (current evidence is largely case-report/cohort level for melioidosis and ESBL-related joint infection)
Clarification of Taiwan market status — drug is currently unlicensed (0 TFDA licenses), so any repurposing pathway would require new licensing/registration
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.