Efficacy and Safety of Teicoplanin in CDAD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Primary Objective:

Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis

Secondary Objective:

Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)

NCT01401023

Diarrhea Clostridium Difficile

COMPLETED NA

Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff

NCT03110133

Clostridium Difficile Infection Recurrence

COMPLETED PHASE2

The Clostridioides Difficile Trial of REC-3964

NCT06536465

Recurrent Clostridioides Difficile Infection

TERMINATED PHASE2

A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

NCT00269399

Clostridium Infections Diarrhea

COMPLETED PHASE3

Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

NCT01591863

Clostridium Difficile-associated Diarrhea

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Approximate 10 weeks

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clostridium Difficile Infection-associated Diarrhea and Colitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Teicoplanin

teicoplanin, administered orally 100-200 mg, twice a day

Group Type EXPERIMENTAL

TEICOPLANIN

Intervention Type DRUG

Pharmaceutical form:solution for oral administration Route of administration: oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TEICOPLANIN

Pharmaceutical form:solution for oral administration Route of administration: oral

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signed Informed Consent.
* Male or female no less than 18 years of age.
* Inpatient with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with \> 3 liquid or unformed bowel movements (UBM) within 24 hours prior to enrollment, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to enrollment.

Exclusion Criteria

* More than one previous episode of CDAD in the 3-month period prior to enrollment.
* Evidence of life-threatening or fulminant CDAD.
* Likelihood of death within 72 hours from any cause.
* History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea
* Antimicrobial treatment active against CDAD administered for \> 24 hours except for metronidazole treatment failures (MTF).
* Known hypersensitivity or contraindication to teicoplanin.
* Pregnant or nursing females.
* Unable or unwilling to comply with all protocol requirements.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No