Clinical trial • Not applicable • Infectious Disease|Other

Rifampicin for Hidradenitis suppurativa | Prosthetic joint infection | Fracture-related infection

Not applicable trial of Rifampicin for Hidradenitis suppurativa | Prosthetic joint infection | Fracture-related infection.

Overview

Trial Therapeutic Area
Infectious Disease|Other
Trial Disease
Hidradenitis suppurativa | Prosthetic joint infection | Fracture-related infection
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-10-2024
First CTIS Authorization Date
14-01-2025

Trial design

Cohorts compare clindamycin monotherapy (Cohort 1 & 2) versus clindamycin + rifampicin combination therapy (Cohort 3 & 4); no formal comparator drug dose/schedule specified in the record.-controlled Not applicable trial across 1 site in Belgium.

Comparator
Cohorts compare clindamycin monotherapy (Cohort 1 & 2) versus clindamycin + rifampicin combination therapy (Cohort 3 & 4); no formal comparator drug dose/schedule specified in the record.
Target Sample Size
40

Eligibility

Recruits 40 Voluntary written informed consent of the participant or their legally authorized representative is required prior to any screening procedures (inclusion criterion). The record indicates isVulnerablePopulationSelected: false; no specific vulnerable population or assent process for minors is indicated..

Pregnancy Exclusion
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
Vulnerable Population
Voluntary written informed consent of the participant or their legally authorized representative is required prior to any screening procedures (inclusion criterion). The record indicates isVulnerablePopulationSelected: false; no specific vulnerable population or assent process for minors is indicated.

Inclusion criteria

  • {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n- At least 18 years of age at the time of signing the Informed Consent Form (ICF)\n- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n- A BMI < 30 (Cohort 1&3) or BMI ≥ 30 (Cohort 2&4)\n- Initiation of clindamycin monotherapy (Cohort 1&2) or initiation of clindamycin/rifampicin combination therapy (Cohort 3&4)\n- For PJIs and FRIs only: Positive culture of Staphylococcus spp. sensitive to clindamycin and rifampicin"}

Exclusion criteria

  • {"criterion_text":"- Participant has a history of allergic reaction to clindamycin or rifampicin\n- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol\n- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial\n- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive\n- Participation in an interventional Trial with an investigational medicinal product (IMP) or device\n- Recent (2 weeks) or concomitant use of CYP3A4 inducers\n- Recent (5 days) or concomitant use of CYP3A4 inhibitors\n- Liver impairment as defined by a Child Pugh score 7 or higher at baseline"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Pharmacokinetic parameters (AUC, Vd, Clearance, Elimination half-life)","definition_or_measurement_approach":"Measurement of pharmacokinetic parameters (AUC, volume of distribution (Vd), clearance, elimination half-life) from plasma concentration-time data (PK analysis)."}

Secondary endpoints

  • {"endpoint_text":"- Effectiveness of treatment","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Clinical cure","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
40
Recruitment Window Months
48
Consent Approach
Voluntary written informed consent must be obtained from the participant or their legally authorized representative prior to any screening procedures (inclusion criterion). Subject information and informed consent form documents are provided in English, French and Dutch (L1_ICF_EN, L1_ICF_FR, L1_ICF_NL). No assent process for minors is described (study enrols adults ≥18 years).

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Belgium

Earliest CTIS Part Ii Submission Date
12-12-2024
Latest Decision Or Authorization Date
14-01-2025
Processing Time Days
33
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
UZ Leuven
Department Name
Traumatology
Principal Investigator Name
Willem-Jan Metsemakers
Principal Investigator Email
willem-jan.metsemakers@uzleuven.be
Contact Person Name
Willem-Jan Metsemakers

Sponsor

Primary sponsor

Full Name
UZ Leuven
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
RIFAMPICIN
Active Substance
Rifampicin
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Dose Levels
Max daily dose 900 mg; max total dose 450 mg
Maximum Dose
900 mg per day
Investigational Product Name
CLINDAMYCIN
Active Substance
Clindamycin hydrochloride
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Dose Levels
Max daily dose 1800 mg; max total dose 600 mg
Maximum Dose
1800 mg per day
Combination Treatment
Yes

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