Study on the Effectiveness of Clarithromycin and Other Drug Combinations for Patients with Uncomplicated Staphylococcus aureus Blood Infection

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What is this study about?

This clinical trial is focused on studying the effectiveness of different durations of antibiotic treatment for a condition known as Staphylococcus aureus bacteremia. This condition occurs when the bacteria Staphylococcus aureus enters the bloodstream, potentially leading to serious infections. The study aims to compare the outcomes of patients receiving either seven or fourteen days of antibiotic treatment to determine which duration is more effective in preventing the return of the infection and ensuring patient survival.

The antibiotics being studied include several well-known medications such as Clarithromycin, Meropenem, Ceftriaxone, Cefotaxime, Piperacillin/Tazobactam, Vancomycin, Dicloxacillin, Flucloxacillin, Linezolid, Clindamycin, Levofloxacin, Moxifloxacin, Amikacin, Gentamicin, Benzylpenicillin, Cloxacillin, and Daptomycin. Some patients will receive a placebo, which is a substance with no active medication, to help compare the effects of the antibiotics. The purpose of the study is to find out if a shorter treatment period is just as effective as a longer one, which could help reduce side effects and healthcare costs.

Participants in the study will be randomly assigned to receive either seven or fourteen days of treatment. They will be monitored for 90 days after the start of the treatment to check for any signs of the infection returning or any other health issues. The study will also look at the overall health and survival of the participants during this period. This research is important for improving the treatment of Staphylococcus aureus bacteremia and ensuring patients receive the most effective care.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. One group will receive 7 days of antibiotic treatment, while the other group will receive 14 days of treatment.

The purpose of this randomization is to compare the effectiveness of the two different treatment durations.

2 treatment administration

Participants will receive antibiotics that are effective against Staphylococcus aureus. The specific medication and route of administration will depend on the participant’s condition and the study protocol.

Medications may include options such as clarithromycin (oral), meropenem (intravenous), and others as specified in the study protocol.

3 monitoring and follow-up

Participants will be monitored for any signs of clinical or microbiological failure during the treatment period and up to 90 days after diagnosis.

Regular follow-up appointments will be scheduled to assess the participant’s health status and to collect necessary data for the study.

4 evaluation of outcomes

The primary outcome is the 90-day survival without clinical or microbiological failure or relapse.

Secondary outcomes include all-cause mortality at various time points, microbiological failure, clinical failure, and any severe adverse events.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must have a blood test that shows the presence of Staphylococcus aureus, a type of bacteria.
  • Must have started antibiotic treatment that works against Staphylococcus aureus within 12 hours of the first positive blood test.
  • Must have a body temperature of less than 37.8°C (100°F) at the time of being chosen for the study.
  • Must have a follow-up blood test that shows no Staphylococcus aureus between 48 to 120 hours after the initial diagnosis of the infection.

Who Cannot Join the Study?

  • Patients with a different type of infection other than Staphylococcus aureus bacteremia cannot participate. Staphylococcus aureus bacteremia is a condition where a specific type of bacteria, called Staphylococcus aureus, is present in the blood.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, 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
Bispebjerg Hospital Copenhagen Denmark

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Lillebaelt Hospital Kolding Denmark
Gentofte Hospital Hellerup Denmark
Sygehus Soenderjylland Soenderborg Aabenraa Denmark
Hvxjmpel Hfnzjtip Hvidovre Denmark
Hjsohpnp Hdftjvyn Hillerød Denmark
Hrtsjg Hkhdwfea Herlev Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
20.07.2018

Trial locations

Antibiotics are used in this clinical trial to treat uncomplicated Staphylococcus aureus bacteremia. The study aims to compare the effectiveness of a 7-day course versus a 14-day course of antibiotic treatment. Antibiotics help to kill or stop the growth of bacteria causing the infection, and the trial is investigating whether a shorter treatment duration is as effective as a longer one in preventing mortality and recurrence of the infection.

Investigated diseases:

Staphylococcus aureus bacteremia – This disease is an infection where the bacteria Staphylococcus aureus enter the bloodstream. It can occur when bacteria from a skin infection or other source spread into the blood. The condition can lead to symptoms such as fever, chills, and low blood pressure. As the infection progresses, it may affect various organs, potentially leading to complications like endocarditis or osteomyelitis. The disease requires careful monitoring to prevent further spread and complications. It is important to manage the infection promptly to avoid severe outcomes.

Trial ID:
2024-519186-21-01
NCT ID:
NCT03514446
Trial Phase:
Therapeutic confirmatory (Phase III)

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