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Cancelled by the investigator Effect of Antibiotic Treatment Course on Clinical Outcome After Two-Stage Revision of Prosthetic Joint Infection: a Multicenter Prospective Clinical Study

Effect of Antibiotic Treatment Course on Clinical Outcome After Two-Stage Revision of Prosthetic Joint Infection: a Multicenter Prospective Clinical Study

Status
Unknown
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027089
Enrollment
Unknown
Registered
2019-10-31
Start date
2019-11-01
Completion date
Unknown
Last updated
2020-05-04

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

Conditions

Prosthetic joint infection

Interventions

Long- course antibiotic treatment group:After receiving intravenous antibiotics treatment for 2 weeks, continue to receive oral antibiotics treatment for 10 weeks.
Medium-course antibiotic treatment group:After receiving intravenous antibiotic treatment (set for 2 weeks according to the extended culture time), oral antibiotics were switched to oral antibiotics f
Short -course antibiotic treatment group:Only receiving intravenous antibiotics treatment for 2 weeks.

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. A diagnosis of PJI was made according to MSIS criteria; 2. Positive microbial culture or next-generation sequencing results confirmed by experts as pathogenic bacteria; 3. Chronic infection is defined as non-acute blood-borne infection that occurs 4 weeks after initial replacement. 4. Received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision. 5. Aged >= 18 years; 6. The patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. He has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study.

Exclusion criteria

Exclusion criteria: 1. Infected by fungi or mycobacteria; 2. Multi-drug resistant bacteria infection; 3. Various reasons lead to the change of the operation plan, such as one-stage revision or joint fusion and other operations; 4. Positive bacterial culture during two-stage revision; 5. Patients have other diseases that may affect the results, such as immune deficiency and liver and kidney insufficiency; 6. Life expectancy is less than half a year; 7. Researchers judge that patients no longer meet the standards of the study due to compliance problems.

Design outcomes

Primary

MeasureTime frame
Clearance rate of infection;Adverse events related to PJI;

Secondary

MeasureTime frame
Time of replanting;Functional score after replantation;The rate of prosthesis loosening after replantation, the rate of revision, and the rate of prosthesis removal required;Incidence of antibiotic-related complications;

Countries

China

Contacts

Public ContactZhang Wenming

The First Affiliated Hospital of Fujian Medical University

zhangwm0591@fjmu.edu.cn+86 0591-87982113

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026