Overview
Sponsor-declared trial summary
Prophylaxis (antibiotics) during maternal or fetal surgery
The primary aim is to describe the pharmacokinetics of clindamycin and its metabolites during pregnancy, in the relevant compartments (maternal plasma, amniotic fluid) during and following obstetric or fetal surgery by performing a population pharmacokinetics analysis approach.
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 11 Dec 2023 → 17 Dec 2024
- Decision date (initial)
- 2023-08-30
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- KU/UZ Leuven
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Prophylaxis
The primary aim is to describe the pharmacokinetics of clindamycin and its metabolites during pregnancy, in the relevant compartments (maternal plasma, amniotic fluid) during and following obstetric or fetal surgery by performing a population
pharmacokinetics analysis approach.
Secondary objectives 1
- The secondary aim is to pool or merge the datasets to other datasets, as reported in the literature, to further validate and explore clindamycin's pharmacokinetic and its covariates during pregnancy and in peripartum.
Conditions and MedDRA coding
Prophylaxis (antibiotics) during maternal or fetal surgery
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures, 2. Singleton and twin pregnancy that fulfill criteria for fetal and obstetric interventions in the second and third trimester of pregnancy, 3. Admitted and hospitalized at the obstetrics surgery ward, 4. Monochorionic twin pregnancy identified to have twin-twin transfusion syndrome (TTTS) or selective fetal growth restriction (sFGR) requiring fetoscopic laser surgery (FLS), 5. Singleton pregnancy undergoing fetal interventions or surgery for example for Congenital Diaphragmatic Hernia (CDH) or Myelomeningocele (MMC), 6. Planned (prescribed) IV dosing of clindamycin as prophylaxis before surgery.
Exclusion criteria 1
- 1. Participant has pre-existing type I diabetes, 2. Any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol, 3. Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial, 4. Participation in an interventional Trial with an investigational medicinal product (IMP) or device, 5. Contraindication for clindamycin (non-limitative: hypersensitivity,...), 6. Treatment with CYP450 inductor within 14 days before clindamycin initiation (e.g., carbamazepine, efavirenz).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- A population pharmacokinetic analysis approach will be performed, comparing the data on PK already reported in adults or other pregnant women and the newly collected data during pregnancy. The quality of fit of the pharmacokinetic model to the data will be sought by NONMEM's objective function and by visual examination of plots of observed vs predicted concentrations. Clindamycin concentrations in maternal plasma and amniotic fluid will be measured at the different sample collection timepoints.
Secondary endpoints 1
- Pharmacokinetic analysis, including the covariates of interest or relevant clinical characteristics i.e., body weight, length, age, body surface area (BSA), gestational age, type of delivery, intercurrent co-morbidity (e.g., renal and hepatic dysfunction, hypothermia, hypothyroidism), other parenteral or other co-medications.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Dalacin C 600 mg solution injectable
PRD411325 · Product
- Active substance
- Clindamycin Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01FF01 — CLINDAMYCIN
- Marketing authorisation
- BE092215
- MA holder
- PFIZER S.A. (BELGIUM)
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- Sofia Mastrodima-Polychroniou
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Sofia Mastrodima-Polychroniou
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 0 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-12-11 | 2024-12-17 | 2023-12-18 | 2024-12-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Intermediate trial report for lay person | 2025-12-23T11:17:10 | Submitted | Laypersons Summary of Results |
Documents 1 file
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Intermediate trial report for lay person | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-05 | Belgium | Acceptable 2023-08-30
|
2023-08-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-25 | Acceptable 2023-08-30
|
||
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-09-25 | Belgium | 2023-09-25 |