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Multicenter before-and-after comparative study on the safety of therapeutic drug monitoring for linezolid-induced thrombocytopenia

Multicenter before-and-after comparative study on the safety of therapeutic drug monitoring for linezolid-induced thrombocytopenia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240652
Enrollment
60
Registered
2025-01-31
Start date
2025-09-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gram-positive bacterial infections

Interventions

Linezolid tablets/injections are initiated as standard treatment based on the physician's decision (typically 1200 mg/day). In cases where oral administration is not feasible due to gastrointestinal a

Sponsors

Hashimoto Hideki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Intervention Group 1. Patients receiving inpatient or outpatient care at Tsukuba University Hospital, Hitachi General Hospital, or Tsukuba Medical Center Hospital 2. Patients scheduled to receive linezolid for 7 days or more 3. Patients who underwent blood tests between 3 days prior to and the day of linezolid initiation 4. Patients with platelet count or more 75000/micro liter at linezolid initiation 5. Patients within 3 days after linezolid initiation 6. Patients who provided written informed concent either personally or through a proxy (limited to relatives) Control Group 1. Patients who received linezolid for 7 days or more at Tsukuba University Hospital, Hitachi General Hospital, or Tsukuba Medical Center Hospital between January 2015 and May 2023 2. Patients who underwent blood tests between 3 days prior to and the day of linezolid initiation 3. Patients with platelet count or more 75000/micro liter at linezolid initiation

Exclusion criteria

Exclusion criteria: 1) Patients deemed inappropriate for this study by the investigators 2) Patients who refused enrollment in the opt-out study (control group)

Design outcomes

Primary

MeasureTime frame
Time to onset of thrombocytopenia after linezolid initiation

Secondary

MeasureTime frame
1. Time to onset of severe thrombocytopenia after linezolid initiation 2. Incidence rate of severe thrombocytopenia during the linezolid treatment period 3. Incidence rate of thrombocytopenia on days 3, 7+-1, 14+-2, and 28+-2 from linezolid initiation 4. Incidence rate of severe thrombocytopenia on days 3, 7+-1, 14+-2, and 28+-2 from linezolid initiation 5. Mortality rate at 30 days from linezolid initiation 6. Treatment success rate at 30 days from linezolid initiation 7. Discontinuation rate of linezolid due to adverse events 8. Duration of linezolid administration 9. Serum concentration of linezolid 10. Daily dose and cost of linezolid administration 11. Immature platelet count and reticulocyte count on days 3, 7+-1, 14+-2, and 28+-2 from linezolid initiation

Contacts

Public ContactNaoaki Hashimoto

University of Tsukuba Hospital

hashimoto.naoaki.aw@ms.hosp.tsukuba.ac.jp+81-29-853-7905

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026