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Study on Shortened Antibiotic Treatment for Gram-negative Bacteremia in Hospitalized Adults Using Pivmecillinam Hydrochloride and Drug Combination

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What is this study about?

This clinical trial is focused on studying the treatment of Gram-negative bacteremia, a type of blood infection caused by certain bacteria. The study aims to evaluate the effectiveness and safety of a shorter course of antibiotic treatment, specifically 5 days, compared to the traditional 7 days or more. The antibiotics being studied include Selexid (containing pivmecillinam hydrochloride), Ciprofloxacin, Bioclavid (containing amoxicillin and clavulanic acid), Trimopan (containing trimethoprim), Nitrofurantoin, Nebcina (containing tobramycin), Piperacillin/Tazobactam, Sulfametoxazol med trimetoprim, Sulfametizol, Meropenem, Hexamycin (containing gentamicin), Ciprofloxacin Fresenius Kabi, Ampicillin, Ertapenem, and Ceftazidim. Some of these medications are administered as tablets, while others are given as injections or infusions.

The purpose of the study is to determine if a shorter duration of antibiotic treatment is just as effective and safe for treating Gram-negative bacteremia that originates from a urinary tract infection in adults who are otherwise healthy. Participants in the study will receive either a 5-day or a longer course of antibiotics, and their health will be monitored to assess the outcomes. The study will track various health indicators, including survival rates and any potential side effects of the antibiotics, over a period of up to 90 days.

Participants will be randomly assigned to one of the treatment groups, and the study will not be blinded, meaning both the participants and the researchers will know which treatment is being administered. The study is designed to ensure that all participants receive appropriate care and that their health is closely monitored throughout the trial period. The ultimate goal is to find a treatment approach that is both effective and minimizes the duration of antibiotic use, which can help reduce the risk of antibiotic resistance and other complications.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age over 18 years, a positive blood culture for Gram-negative bacteria, and evidence of a urinary tract infection.

Consent is required, both orally and in writing, to participate in the study.

2 initial treatment

Antibiotic treatment begins within 12 hours of the first positive blood culture. The treatment is aimed at bacteria causing the infection.

The initial treatment phase involves monitoring vital signs to ensure stability, including temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation.

3 randomization

Participants are randomly assigned to receive either a short course of antibiotics for 5 days or a longer course of 7 days or more.

The goal is to compare the effectiveness and safety of the shorter treatment duration against the longer one.

4 medication administration

Medications used in the study include Selexid, Ciprofloxacin, Bioclavid, and others, administered either orally or through injection/infusion depending on the specific drug.

The frequency and dosage depend on the specific medication and the treatment group assigned.

5 monitoring and follow-up

Participants are monitored for 90 days to assess survival without treatment failure, adverse events, and any need for additional antibiotics.

Regular follow-ups are conducted to evaluate the total duration of antibiotic treatment, hospital stay, and any re-admissions.

6 end of study

The study concludes with an assessment of the primary and secondary endpoints, including survival rates and any adverse effects experienced during the trial.

The estimated end date for the study is October 1, 2026.

Who Can Join the Study?

  • Must be over 18 years old.
  • Must have a blood test that shows the presence of Gram-negative bacteria. These are a type of bacteria that can cause infections.
  • Must have signs of a urinary tract infection, which could be a positive urine test or symptoms like pain when urinating or frequent urination.
  • Must have started antibiotic treatment that works against Gram-negative bacteria within 12 hours of the first positive blood test.
  • Must have a body temperature below 37.8°C at the time of joining the study.
  • Must be clinically stable at the time of joining the study, meaning:
    • Blood pressure is higher than 90 mm Hg.
    • Heart rate is less than 100 beats per minute.
    • Breathing rate is less than 24 breaths per minute.
    • Oxygen level in the blood is more than 90%.
  • Must provide both oral and written agreement to participate in the study.

Who Cannot Join the Study?

  • Patients who are not adults. This means anyone under the age of 18 cannot participate.
  • Patients who have a weakened immune system. This refers to people whose bodies have a harder time fighting infections.
  • Patients who are part of a vulnerable population. This includes groups of 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
Bispebjerg Hospital Copenhagen Denmark

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Aalborg University Hospital Aalborg Denmark
Gentofte Hospital Hellerup Denmark
Huuielhe Hcafwhij Hvidovre Denmark
Haqnqc Hrsormeh Herlev Denmark
Hnmekidp Hrhczcju Hillerød 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
11.03.2020

Trial locations

Investigated drugs:

Antibiotic Treatment
This study involves the use of antibiotics to treat Gram-negative bacteremia, which is a type of bacterial infection in the blood. The focus is on patients who have this infection originating from a urinary tract infection. The trial compares the effectiveness and safety of a shorter course of antibiotics, lasting 5 days, against the traditional longer treatment duration of 7 days or more. The goal is to determine if the shorter treatment is just as effective and safe for patients.

Gram-negative Bacteremia – This condition occurs when bacteria classified as Gram-negative enter the bloodstream, leading to an infection. These bacteria have a unique cell wall structure that makes them resistant to certain antibiotics. The infection often originates from another site in the body, such as the urinary tract, and can spread quickly. Symptoms may include fever, chills, and low blood pressure. If not managed, the infection can affect multiple organs and systems. The progression of the disease depends on the body’s response and the effectiveness of the treatment.

Trial ID:
2024-514900-16-00
Protocol code:
2019-003282-17
NCT ID:
NCT04291768
Trial Phase:
Therapeutic confirmatory (Phase III)

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