Study on the Effect of Rifampicin and Drug Combination for Patients with Staphylococcus aureus Bacteremia

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What is this study about?

This clinical trial is focused on studying the effects of different treatments for Staphylococcus aureus bacteremia, a serious infection caused by the bacteria Staphylococcus aureus that enters the bloodstream. The trial will explore the impact of various antibiotics on the survival of patients over a period of 90 days. The antibiotics being studied include Rifampicin, Doxycycline, Co-trimoxazole, Cefazolin, Flucloxacillin, Daptomycin, Benzylpenicillin Sodium, Amoxicillin, Levofloxacin, Clindamycin, Cefalexin, Moxifloxacin, Linezolid, Clindamycin Hydrochloride, and Vancomycin. Some participants will receive a placebo for comparison.

The purpose of the study is to examine how these treatments affect the overall survival of patients with this infection. Participants will be monitored for 90 days to assess their health outcomes, including survival rates and any side effects from the treatments. The study will also look at how long patients stay in the hospital and their recovery progress.

Throughout the study, participants will receive either one of the antibiotics or a placebo, and their health will be closely observed. The trial aims to provide valuable information on the effectiveness of these antibiotics in treating Staphylococcus aureus bacteremia and improving patient outcomes. This research could help guide future treatment options for this serious infection.

1 entry into the trial

Upon joining the study, you will be informed about the trial’s purpose, which is to examine the effect on all-cause mortality at 90 days of a range of interventions in patients with Staphylococcus aureus bacteremia.

You will be asked to provide consent to participate in the trial, acknowledging that you understand the procedures and potential risks involved.

2 initial assessment

An initial assessment will be conducted to confirm that Staphylococcus aureus has been grown from at least one blood culture.

You must be admitted to a participating hospital at the time of this assessment.

3 treatment allocation

You will be randomly assigned to receive one of the following medications: rifampicin, doxycycline, co-trimoxazole, cefazolin, flucloxacillin, daptomycin, benzylpenicillin sodium, amoxicillin, levofloxacin, clindamycin, cefalexin, moxifloxacin, linezolid, clindamycin hydrochloride, or vancomycin.

The route of administration will vary depending on the medication, including oral, intravenous, or IV infusion.

4 medication administration

You will receive the assigned medication according to the specified dosage and frequency, which will be explained to you by the medical team.

The duration of administration will be determined based on your response to the treatment and the study protocol.

5 monitoring and follow-up

Throughout the trial, your health will be closely monitored to assess the effectiveness of the treatment and to identify any side effects.

Follow-up assessments will occur at 14, 28, 42, and 90 days after entering the trial to evaluate your health status and any changes in your condition.

6 completion of the trial

At the end of the 90-day period, a final assessment will be conducted to determine the overall outcome of the treatment.

You will be informed about the results of the trial and any further steps that may be necessary for your health care.

Who Can Join the Study?

  • The patient must have a blood test that shows the presence of Staphylococcus aureus, a type of bacteria.
  • The patient must be admitted to a hospital that is participating in the study at the time they are being considered for the study. If the patient has passed away, they must have been admitted to the hospital from the time the blood test was taken until the time they were considered for the study.
  • The study is open to both male and female patients.
  • The study includes patients from certain age groups, specifically adults and older adults.
  • The study does not include vulnerable populations, which means it is not designed for groups that might need special protection or care.

Who Cannot Join the Study?

  • Patients with a different type of infection other than Staphylococcus aureus bacteremia cannot participate. Staphylococcus aureus bacteremia is a type of bacterial infection in the blood.
  • Patients who are under 18 years old or over 65 years old cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of severe allergic reactions to the study medication cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients with a medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Medizinische Hochschule Hannover Hanover Germany
CHU Grenoble Alpes La Tronche France
CHU Caremeau Nimes France
University Medicine Greifswald Greifswald Germany
Region Vaestmanland Vasteras Sweden

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Le Mans Le Mans France
Region Jaemtland Haerjedalen Ostersund Sweden
Bernhoven B.V. Uden The Netherlands
Hospital Raymond Poincare Garches France
Hzbwvnr Pnuwllzhlfhwggxi Rozleb Rennes France
Uzmtqjtkke Hphzwmqi Cvutvux Cologne Germany
Rgcmzg Sjhpr Srwnqj Uqqnffjhsttfnrtnydp Lund Sweden
Uvrfzhpxjmix Mmitkbg Cxrlhvk Upvsbur Utrecht The Netherlands
Cwgahpu Uuawppuwcpizpzsybvik Btgytk Kvb Berlin Germany
Cuqast Hldjymymfhu Rkhranlq Uyyxnoshnagau Dg Tzdae Tours France
Czngui Hmxjetdflqm Uqvasjvooeeoy Dt Mwgtypdchcr Montpellier France
Cohocs Haulnynmzyg Di Ls Ckxj Baoxby Bayonne France
Uhomffjfpxtjvzofqcfyy Hmrnijqnxv Aie Heidelberg Germany
Jaqbigiquldqdyxluxdbdbuzfd Gjhjibu Giessen Germany
Mtwlzqa Cljjty &ltcnef Uznihobnal Op Fiqfqled Freiburg Im Breisgau Germany
Uchzrqzrbgnsfkvyudcsk Wfdpmdjeq Akh Wuerzburg Germany
Uhlhettkry Mlkcxev Cwiucp Hnggkarqngpqpsmzc Hamburg Germany
Idogqylh fkin Kpovxjbmn Tjpruspgyjedacxuqrl usg Ighajrovfaxj Uxe gjoum Ulm Germany
Uqfyxlixypgg Mmoufsf Csgtbmi Giuibfooi Groningen The Netherlands
Uwvzvqdawhdldedmydgcu Szqjfrolrvdryyfvhr Adm Kiel Germany
Pvgauwujx Hoextwmi Bordeaux France
Csynvq Hxaexgwjmxe Rkswkyme Dnldeypyzulbhu Angers France
Cyhgxx Havydtsuayf Dp Phuivixtp Perpignan France
Cirfso Hgwlrrsrrjt Idogfmdxjhvot Dg Coppvwflefa Quimper France
Cqm Dh Dmfly Dijon France
Cqq Cmnb Ngocehgps Caen France
Rvxcwb Vnaooxsysxuvm Umea Sweden
Hoznlqt ljnwaxiumexbjt 1 Nice France
Ciz Gczhxxadck Les Abymes France
Hkbrjhp Scygw Ahegaxo Paris France
Czj Lohvfcj Limoges France
Ck Pej Pau France
Hljgsva dkznkajkojabp dyh Asvrpx Lmvcjyw Marseille France
Cwty Vzt Omamxjscj Ueowzheaiyej Oozhupyqe Oldenburg In Holstein Germany
Dcmslrhqgi Zxjchsjosb Hoorn The Netherlands
Crf Dz Mnqpjtdpam Fort De France France
Nzssqb Hvanuwu Cchlm Spbycrylpq STRASBOURG, Alsace France
Uebvbjfzimdhjfixtrufy Rqpxkiielg Awi Regensburg Germany
Apwfvxolof Pwfwxhdr Heakacab Dn Poqrg Paris France
Kvwdiapd Sgo Gbsyg gfknw Leipzig Germany
Smixekuzf Rbhzxbz Uahfpwugra Mduspol Cmmrvp Nijmegen The Netherlands
Bolpwveq Unzgihhmtz Hjmswgbc Cmygzi Besançon France
Lyabyt Mxolhbscxs Uulmzkzacp Oy Mybmkz Munich Germany
Cbqpvl Halfsbdorqd Dw Pxatcdxjn Perigueux France
Skjxcqotx Tjhggr Zwsfdpyklrpzng Emmen The Netherlands
Gvehgl Ugcnjmbjjs Focovklwe Frankfurt Germany
Rszfrrpof Zxvnkyizrw Stpkqgqvq Arnhem The Netherlands
Sfjqbztig Mjcnxpt Zonrxohhao Groningen The Netherlands
Jjhnmt Brcyw Zjusdszpsf Sjvcxxrad S-Hertogenbosch The Netherlands
Uzbuypvjsxkexnylsrhlp Axdflyfh Augsburg Germany
Ujuxychhnu Hkqljmevg Pgrev Sevpabyzssd Cygqxos Fomi Paris France
Rrhkdv Soygm Huhsxuyzqlz Hwnarjgh Helsingborg Sweden
Szdgphlbr Hgwwhhkbxpgzimhj Gsmqvhtjmptbiceuhx Skovde Sweden
Ibvfxl Zkgqhqgcna Rotterdam The Netherlands
Ceinpz Hqfhcuugofc De Nqwuo Niort France
Hjcnduuu Kvgsahochikgbiq Aqrqw Le Kremlin-Bicetre France
Cul Nxkizp Nantes France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.08.2023
Germany Germany
Recruiting
01.08.2023
Sweden Sweden
Recruiting
01.08.2023
The Netherlands The Netherlands
Recruiting
01.08.2023

Trial locations

{
“authorizedApplication.authorizedPartI.products.0”: [
{
“productName”: “Vancomycin”,
“description”: “Vancomycin is an antibiotic used to treat serious infections caused by bacteria. It works by stopping the growth of bacteria.”
},
{
“productName”: “Daptomycin”,
“description”: “Daptomycin is an antibiotic that fights bacteria in the body. It is used to treat certain infections caused by bacteria.”
},
{
“productName”: “Linezolid”,
“description”: “Linezolid is an antibiotic that is used to treat infections, including pneumonia and skin infections. It works by stopping the growth of bacteria.”
},
{
“productName”: “Ceftaroline”,
“description”: “Ceftaroline is an antibiotic used to treat bacterial infections, including skin infections and pneumonia. It works by killing bacteria or preventing their growth.”
}
]
}

Vancomycin is an antibiotic used to treat serious infections caused by bacteria. It works by stopping the growth of bacteria.

Daptomycin is an antibiotic that fights bacteria in the body. It is used to treat certain infections caused by bacteria.

Linezolid is an antibiotic that is used to treat infections, including pneumonia and skin infections. It works by stopping the growth of bacteria.

Ceftaroline is an antibiotic used to treat bacterial infections, including skin infections and pneumonia. It works by killing bacteria or preventing their growth.

Investigated Diseases:

Staphylococcus aureus bacteremia – Staphylococcus aureus bacteremia is a condition where the bacterium Staphylococcus aureus enters the bloodstream. This can lead to a systemic infection, affecting various organs and tissues. The disease often begins with symptoms such as fever, chills, and low blood pressure. As it progresses, it can cause complications like endocarditis, osteomyelitis, and abscess formation in different parts of the body. The bacteria can spread to the heart, bones, joints, and other areas, leading to more severe health issues. The progression of the disease depends on factors like the patient’s immune system and the presence of any underlying health conditions.

Trial ID:
2023-503582-35-00
NCT ID:
NCT05137119
Trial Phase:
Therapeutic confirmatory (Phase III)

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