Study on Oral Antibiotics Moxifloxacin, Linezolid, and Metronidazole for Patients with Bacterial Brain Abscess

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What is this study about?

This clinical trial is focused on studying the treatment of a brain abscess, which is a collection of pus that can form in the brain due to an infection. The study aims to compare the effectiveness of oral antibiotics to intravenous (IV) antibiotics in treating this condition. The oral antibiotics being tested include Moxifloxacin, Linezolid, Metronidazole, Clindamycin, and Amoxicillin. The IV antibiotics being used in the study are Cefotaxime, Meropenem, and Ceftriaxone. A placebo may also be used in the study.

The purpose of the study is to determine if oral antibiotics are as effective as IV antibiotics in treating brain abscesses. Participants in the study will receive either oral or IV antibiotics for a period of time, and their progress will be monitored over several months. The study will assess various outcomes, including the risk of complications such as the rupture of the brain abscess, the need for additional medical procedures, and the overall recovery of the patient.

Throughout the study, participants will be regularly evaluated to ensure their safety and to monitor the effectiveness of the treatment. The study will last for a total of 52 weeks, with follow-up assessments conducted at different intervals to track the participants’ health and recovery. The goal is to provide valuable information on whether oral antibiotics can be a viable alternative to IV antibiotics for treating brain abscesses, potentially offering a more convenient treatment option for patients.

1 joining the trial

Upon joining the trial, you will be assessed to ensure you meet the necessary criteria. This includes being over 17 years old, having a brain abscess confirmed by imaging, and being able to take oral medications.

You must have already received intravenous antibiotics for at least 14 days before joining the trial, and no further surgical procedures for the brain abscess should be planned.

2 randomization

You will be randomly assigned to receive either oral or intravenous antibiotics. This is done to compare the effectiveness of the two treatment methods.

3 treatment phase

If assigned to oral antibiotics, you may receive medications such as moxifloxacin hydrochloride, linezolid, metronidazole, amoxicillin, or clindamycin. These are taken by mouth as tablets or capsules.

If assigned to intravenous antibiotics, you may receive medications such as cefotaxime, meropenem anhydrous, or ceftriaxone sodium. These are administered through a vein.

The treatment will continue for at least 14 days after randomization.

4 follow-up assessments

You will have regular follow-up assessments to monitor your health and the effectiveness of the treatment. These assessments will occur at the end of treatment, and at 3, 6, and 12 months after randomization.

The assessments will include checking for any recurrence of the brain abscess, any new symptoms, and overall health status.

5 completion of trial

The trial will conclude with a final assessment at 12 months after randomization. This will help determine the long-term effectiveness and safety of the treatment you received.

Who Can Join the Study?

Must be older than 17 years.
Have symptoms and brain scans that match a brain abscess.
The doctor has decided to treat you for a brain abscess.
Must be able to take medicines by mouth.
Have already received recommended intravenous (IV) antimicrobials (medicines given through a vein to fight infection) for at least 14 days in a row before joining the study, and no more procedures to remove the brain abscess are planned.
Expected to continue treatment for at least another 14 days after joining the study.
No worsening of neurological problems or new neurological symptoms (except for seizures) within 5 days before joining the study.

Who Cannot Join the Study?

Patients with a brain abscess cannot participate. A brain abscess is a collection of pus that forms in the brain due to an infection.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Assistance Publique Hopitaux De Paris	Paris	France
Aalborg University Hospital	Aalborg	Denmark
Centre Hospitalier Universitaire De Nice	Nice	France
Rigshospitalet	Copenhagen	Denmark
Lund University Hospital	Lund	Sweden
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Region Oerebro Laen	Orebro	Sweden
Pellegrin Hospital	Bordeaux	France
Odense University Hospital	Odense	Denmark
Karolinska Institutet	Stockholm	Sweden
Azzierktf Uxu	Amsterdam	The Netherlands
Suawjdyercb Ukcpcymizd Huoklrignvlfmoj Guryhovsktgnioeie	Gothenburg	Sweden
Cjf Cetb Nozrnspjj	Caen	France
Pwokarhqu Umbywzpiel Hpeylavf	Perpignan	France
Cwhokx Hhiwdcizacg Abkdyl Gazfvvpv	Epagny Metz Tessy	France
Cqo Dj Dfgsu	Dijon	France
Erqjyqwobinwepadpave Zgppwmpsgx	Tilburg	The Netherlands
Cylnrs Hamuhpinfxs Eq Utvpbxatimtya Dw Lqsamgf	Limoges	France
Ahclwhtfsz Pekabafs Hkdebrpf Dk Psuiw	Paris	France
Amypad Uqumqoakfv Hcmxzzup	Aarhus	Denmark
Ckhkqr Hlbkqibmskq Rrbtxmrk Uxoalzafzzpjt Dm Thvdl	Tours	France
Unktscuidu Hrfreodtv Ppdvq Stzmdlhlnhe Cmehhwr Fyhr	Paris	France
Hdcopnf Hceoc Mxytrq &afdjof 1 rvz Ghjndhe Evbsfe	Creteil	France
Ciw Cuxxe Rhymmdutnzm	Lyon	France

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	02.05.2021
France	Recruiting	02.05.2021
Sweden	Recruiting	02.05.2021
The Netherlands	Recruiting	02.05.2021

Trial locations

Investigated drugs:

Oral Antibiotics are medications taken by mouth to treat infections caused by bacteria. In this trial, they are being tested to see if they are as effective as intravenous (IV) antibiotics in treating bacterial brain abscesses. The goal is to find out if taking antibiotics by mouth can work just as well as receiving them through an IV, which is a method where medicine is given directly into a vein.

Intravenous (IV) Antibiotics are medications given directly into the bloodstream through a vein. This method is often used for serious infections because it allows the medicine to work quickly and effectively. In this trial, IV antibiotics are being compared to oral antibiotics to see if they are more effective in treating bacterial brain abscesses. The study aims to determine if the traditional IV method is necessary or if oral antibiotics can be just as effective.

Investigated diseases:

Brain abscess

Brain abscess – A brain abscess is a collection of pus that forms in the brain due to an infection. It typically occurs when bacteria or fungi enter the brain tissue, often following an infection elsewhere in the body, head injury, or surgery. The abscess can cause swelling and inflammation, leading to increased pressure within the skull. Symptoms may include headache, fever, nausea, vomiting, neurological deficits, and changes in mental status. As the abscess progresses, it can lead to more severe neurological symptoms and complications. The condition requires careful monitoring to prevent further complications.

Trial ID:

2023-505483-11-00

NCT ID:

NCT04140903

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Oral Antibiotics Moxifloxacin, Linezolid, and Metronidazole for Patients with Bacterial Brain Abscess

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?