SYF1149c816a84749e997161d8806c953b4

RecruitingPhase 4

Clindamycin for the treatment of infections: the influence o...

UZ Leuven Source

CTIS (EMA)

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Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 17, 2024
Actual (reported)

Conditions

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Effectiveness of treatment
Clinical cure

Interventions

CLINDAMYCIN Type not reported

RIFAMPICIN Type not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
At least 18 years of age at the time of signing the Informed Consent Form (ICF)

Sponsors & Collaborators

UZ Leuven
Type not reportedlead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Willem-Jan Metsemakers+3216341325 willem-jan.metsemakers@uzleuven.be

Central Study Contacts

Dorian Vanneste

016348102 dorian.vanneste@uzleuven.be

Study Design

Study Type: interventional
Phase: phase 4

Study Record Dates

First Submitted

October 17, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-515872-12-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 05:25:52 UTC

Documents

D1_Protocol 2024-515872-12-00 Redacted

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Phase 4Unknown

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Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa

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A Single-center, Prospective, Self-controlled, Observational Real-world Study of the Efficacy and Safety of Anti-IL-17A/F Monoclonal Antibody Combined With Non-ablative Dot Laser for the Treatment of Mild to Moderate Hidradenitis Suppurativa

Phase 4Not Yet Recruiting

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Phase 4Completed

SYFdeb9146f84cc419eb710348bbb677a1b

Botox Treatment for Patients with Hidradenitis Suppurativa: A Within-Person, Randomized, Double-blind, Controlled Study

Phase 4Recruiting

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.

A BMI < 30 (Cohort 1&3) or BMI ≥ 30 (Cohort 2&4)

Initiation of clindamycin monotherapy (Cohort 1&2) or initiation of clindamycin/rifampicin combination therapy (Cohort 3&4)

You may not qualify if:

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

Contact the study team to confirm eligibility.

D1_Protocol synopsis_ENG_NL_DE_FR 2024-515872-12-00

G2_SmPC Clindamycin

G2_SmPC Rifampicin

K1_Recruitment arrangements

L2_sponsorstatement_redacted

L1_ICF_EN

L1_ICF_FR

L1_ICF_NL

Locations

BE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations