Study on the Safety and Tolerability of Higher Dose Rifampicin for Tuberculosis Patients

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What is this study about?

This clinical trial is focused on studying the disease known as Tuberculosis, which is an infectious disease that primarily affects the lungs. The treatment being tested in this study is a medication called Rifampicin, which is an antibiotic commonly used to treat tuberculosis. The purpose of the study is to evaluate the safety and tolerability of a higher dose of Rifampicin in patients with tuberculosis.

Participants in the study will receive an optimized dose of Rifampicin over a period of six months. The study will monitor the safety of this higher dose by observing the occurrence of liver-related side effects, known as hepatotoxicity, among the participants. The study will also look at other side effects and the overall treatment outcomes at the end of the treatment period.

Throughout the study, participants will be regularly assessed to ensure their safety and to gather information on how their bodies respond to the treatment. The study aims to provide valuable insights into whether a higher dose of Rifampicin can be safely used to improve treatment outcomes for patients with tuberculosis.

1 joining the study

Upon joining the study, informed consent is required. This means agreeing to participate after understanding the study details.

Eligibility is confirmed based on criteria such as age (18 years or older), a diagnosis of tuberculosis, and no known allergies to rifampicin.

2 initial assessment

An initial health assessment is conducted to ensure suitability for the study. This includes a review of medical history and a physical examination.

Female participants of childbearing potential must undergo a pregnancy test and agree to use effective birth control during the study.

3 medication administration

The study involves taking rifampicin orally. The dosage is optimized for safety and effectiveness.

The medication is taken daily for a duration of six months.

4 regular monitoring

Regular check-ups are scheduled to monitor health and any side effects. This includes blood tests to check liver function, as hepatotoxicity (liver damage) is a primary concern.

Participants are observed for any adverse events, which are categorized by severity and relation to rifampicin.

5 midpoint evaluation

At two and three months, evaluations are conducted to assess the progress of treatment. This includes checking for culture conversion, which indicates the effectiveness of the medication.

6 end of treatment assessment

At the end of the six-month treatment period, a final assessment is conducted. This includes determining the treatment outcome based on WHO definitions of cure.

Participants’ health is evaluated to ensure no long-term adverse effects from the medication.

Who Can Join the Study?

The patient has provided informed consent for study participation before any trial-related procedures. This means the patient agrees to join the study after understanding what it involves.
The patient has a diagnosis of pulmonary tuberculosis according to local diagnostic criteria. Pulmonary tuberculosis is a type of tuberculosis that affects the lungs.
The patient is aged 18 years or older on the day they give informed consent.
The patient has no known allergic reactions or toxicity to rifampicin in the past. Rifampicin is a medication used to treat tuberculosis.
Female patients who can have children must have a negative blood pregnancy test and agree to use an effective method of birth control during the study. They should not be breastfeeding during the trial.
The patient will be able to follow the study schedule, as determined by the study investigator.

Who Cannot Join the Study?

Patients with a current or past diagnosis of Tuberculosis cannot participate.
Patients who have experienced hepatotoxicity (liver damage) from medications in the past are excluded.
Patients who are not within the specified age range for the study are not eligible.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
National Institute For Infectious Diseases Lazzaro Spallanzani	Rome	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Azienda Sanitaria Locale Citta Di Torino	Turin	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Sazdoxdse Renulcj Uvqnjjlfrh Mzsrind Cqgxhe	Nijmegen	The Netherlands
Aovrzl Upimgfawmh Hlvhtuin	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.12.2023
Italy	Not yet recruiting	01.12.2023
The Netherlands	Not yet recruiting	01.12.2023

Trial locations

Investigated drugs:

Rifampicin

Rifampicin is a medication used to treat tuberculosis, a serious infection that mainly affects the lungs. In this clinical trial, researchers are testing a higher dose of rifampicin to see if it is safe for patients. They want to find out if this higher dose causes any liver problems, which is a known side effect of the medication. By comparing the effects of the higher dose with the usual dose, the researchers hope to determine if the increased dose is safe and well-tolerated by patients over a six-month treatment period.

Investigated diseases:

Tuberculosis

Tuberculosis – Tuberculosis is an infectious disease caused by the bacterium Mycobacterium tuberculosis. It primarily affects the lungs but can also impact other parts of the body, such as the kidneys, spine, and brain. The disease progresses slowly, with symptoms that may include a persistent cough, chest pain, and coughing up blood. As the infection advances, individuals may experience weight loss, fatigue, fever, and night sweats. Tuberculosis spreads through the air when an infected person coughs or sneezes, making it highly contagious. Without proper management, the bacteria can remain dormant in the body and reactivate later, leading to further complications.

Trial ID:

2023-509885-39-00

Protocol code:

PORT

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Tolerability of Higher Dose Rifampicin for Tuberculosis Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?