Clindamycin for the treatment of infections: the influence of rifampicin and obesity on PK/PD target attainment

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

29 Jul 2025 → ongoing

Decision date (initial)

2025-01-14

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Pharmacogenetic, Efficacy

The aim of the trial is to investigate the exposure to clindamycin and the influence of body weight and concomitant rifampicin treatment.

Conditions and MedDRA coding

Hidradenitis suppurativa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
3. 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.
4. A BMI < 30 (Cohort 1&3) or BMI ≥ 30 (Cohort 2&4)
5. Initiation of clindamycin monotherapy (Cohort 1&2) or initiation of clindamycin/rifampicin combination therapy (Cohort 3&4)
6. For PJIs and FRIs only: Positive culture of Staphylococcus spp. sensitive to clindamycin and rifampicin

Exclusion criteria 8

1. Participant has a history of allergic reaction to clindamycin or rifampicin
2. Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
3. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
4. 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
5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
6. Recent (2 weeks) or concomitant use of CYP3A4 inducers
7. Recent (5 days) or concomitant use of CYP3A4 inhibitors
8. Liver impairment as defined by a Child Pugh score 7 or higher at baseline

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pharmacokinetic parameters (AUC, Vd, Clearance, Elimination half-life)

Secondary endpoints 2

1. Effectiveness of treatment
2. Clinical cure

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Dorian Vanneste

Public contact point

Organisation

UZ Leuven

Contact name

Dorian Vanneste

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications