Clinical trial • Phase III • Infectious Disease

AMOXICILLIN SODIUM for Prosthetic joint infection (hip or knee)

Phase III trial of AMOXICILLIN SODIUM for Prosthetic joint infection (hip or knee).

Overview

Trial Therapeutic Area: Infectious Disease
Trial Disease: Prosthetic joint infection (hip or knee)
Trial Stage: Phase III
Drug Modality: Small molecule|Other

Key dates

Initial CTIS Submission Date: 17-01-2025
First CTIS Authorization Date: 23-01-2025

Trial design

AMOXICILLIN; LINEZOLID; SULFAMETHOXAZOLE AND TRIMETHOPRIM; DOXYCYCLINE; CLINDAMYCIN; FLUCONAZOLE; METRONIDAZOLE; CIPROFLOXACIN; AMOXICILLIN AND BETA-LACTAMASE INHIBITOR (doses/schedules not specified in the record)-controlled Phase III trial across 1 site in Spain.

Comparator: AMOXICILLIN; LINEZOLID; SULFAMETHOXAZOLE AND TRIMETHOPRIM; DOXYCYCLINE; CLINDAMYCIN; FLUCONAZOLE; METRONIDAZOLE; CIPROFLOXACIN; AMOXICILLIN AND BETA-LACTAMASE INHIBITOR (doses/schedules not specified in the record)
Target Sample Size: 20

Eligibility

Recruits 20 No vulnerable populations selected; only adults (Patients over 18 years) are eligible. Informed consent required: 'Patients who sign the informed consent form'..

Vulnerable Population: No vulnerable populations selected; only adults (Patients over 18 years) are eligible. Informed consent required: 'Patients who sign the informed consent form'.

Inclusion criteria

{"criterion_text":"- Patients over 18 years of age\n- Carriers of hip or knee prosthesis, diagnosed with an active infection\n- Without the possibility of curative treatment\n- Patients who sign the informed consent form\n- Monomicrobial infections"}

Exclusion criteria

{"criterion_text":"- Patients with the possibility of curative treatment\n- Patients under 18 years of age\n- Polymicrobial infections\n- Fungal or mycobacterial infections\n- Patients with oral corticosteroids with doses higher than 5 mg/day in the three months prior to inclusion"}

Endpoints

Primary endpoints

{"endpoint_text":"- Clinical course: Presence of exudate, redness of the wound, pain, or other clinical signs of infection.","definition_or_measurement_approach":"Assessment of clinical course by presence of exudate, wound redness, pain, or other clinical signs of infection (clinical examination of infection signs)."}

Secondary endpoints

{"endpoint_text":"- Safety assessment: local and systemic adverse events","definition_or_measurement_approach":"Monitoring and recording of local and systemic adverse events; safety assessment through reported/observed adverse events."}

Recruitment

Planned Sample Size: 20
Recruitment Window Months: 24
Consent Approach: Informed consent obtained from participants; adults only as per inclusion ('Patients who sign the informed consent form'). A Subject Information Sheet and Informed Consent Form for adults is listed (L1_SIS and ICF adults). No assent or parental consent described.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 20

Spain

Earliest CTIS Part Ii Submission Date: 13-12-2024
Latest Decision Or Authorization Date: 23-01-2025
Processing Time Days: 41
Number Of Sites: 1
Number Of Participants: 20

Sites

Site Name: Hospital Universitario Marques De Valdecilla
Department Name: disease infection
Principal Investigator Name: marta Fernandez
Principal Investigator Email: marta.fernandezs@scsalud.es
Contact Person Name: marta Fernandez
Contact Person Email: marta.fernandezs@scsalud.es
Number Of Participants: 20

Sponsor

Primary sponsor

Full Name: Instituto De Investigacion Marques De Valdecilla
Organisation Type: Laboratory/Research/Testing facility
Country Of Registered Address: Spain

Investigational products

Investigational Product Name: AMOXICILLIN
Active Substance: AMOXICILLIN SODIUM
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Maximum Dose: 3000 mg

Investigational Product Name: SULFAMETHOXAZOLE AND TRIMETHOPRIM
Active Substance: BROMHEXINE HYDROCHLORIDE, SULFAMETHOXAZOLE, TRIMETHOPRIM
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Maximum Dose: 1600 mg

Investigational Product Name: AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
Active Substance: AMOXICILLIN SODIUM, CLAVULANIC ACID
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Maximum Dose: 500 mg

Investigational Product Name: METRONIDAZOLE
Active Substance: METRONIDAZOLE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Maximum Dose: 1500 mg

Investigational Product Name: CIPROFLOXACIN
Active Substance: CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Maximum Dose: 1500 mg

Investigational Product Name: CLINDAMYCIN
Active Substance: CLINDAMYCIN HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Maximum Dose: 2400 mg

Investigational Product Name: DOXYCYCLINE
Active Substance: AMBROXOL HYDROCHLORIDE, DOXYCYCLINE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Maximum Dose: 200 mg

Investigational Product Name: LINEZOLID
Active Substance: LINEZOLID
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Maximum Dose: 1200 mg

Investigational Product Name: FLUCONAZOLE
Active Substance: CLOTRIMAZOLE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Maximum Dose: 400 mg

Investigational Product Name: SODIUM CHLORIDE SOLUTION 0.9%
Active Substance: SODIUM CHLORIDE SOLUTION 0.9%
Modality: Other
Routes Of Administration: SUBLINGUAL USE
Route: SUBLINGUAL USE
Maximum Dose: 300 U

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