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Study on the Effectiveness of Co-Trimoxazole for Treating Ventilator-Associated Pneumonia in ICU Patients Compared to a Drug Combination

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for Ventilator-Associated Pneumonia (VAP), a type of lung infection that occurs in people who are on mechanical ventilation in an intensive care unit. The study is investigating the use of a medication called Co-trimoxazole as a treatment option. Co-trimoxazole is a combination of two antibiotics, sulfamethoxazole and trimethoprim, which work together to fight bacterial infections.

The purpose of the study is to determine if Co-trimoxazole is as effective as the best standard treatments currently available for treating VAP. Participants in the study will receive either Co-trimoxazole or another standard treatment, which may include medications like Temocillin, Piperacillin Sodium, Ciprofloxacin, Levofloxacin, Cefotaxime, Ofloxacin, Piperacillin, Ceftriaxone, Imipenem Monohydrate, Amoxicillin Sodium, Aztreonam, Ertapenem, Meropenem, or Cefepime. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatments.

The study will last for a period of up to six weeks, during which participants will be closely monitored. The main focus will be on the participants’ health status 28 days after starting the treatment. Additional observations will include the number of days participants are free from mechanical ventilation, the length of stay in the ICU and hospital, and any side effects or allergic reactions to the medications. The study aims to provide valuable information on the safety and effectiveness of Co-trimoxazole as a treatment for VAP in intensive care settings.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose and procedures. You will be asked to provide consent to participate.

Eligibility criteria include being an adult aged 18 or older, having been on mechanical ventilation for at least five days, and having a confirmed diagnosis of ventilator-associated pneumonia (VAP).

2 initial treatment

You will receive an initial treatment with an appropriate antibiotic therapy for 24 to 72 hours. This treatment is based on the bacteria causing the infection and their susceptibility to antibiotics.

3 randomization

After the initial treatment, you will be randomly assigned to receive either cotrimoxazole or the best standard of care as a de-escalation treatment. This means that the treatment will be adjusted to a less intensive therapy.

4 treatment administration

The medication will be administered through an intravenous infusion. This involves delivering the medication directly into your bloodstream through a vein.

The duration and frequency of the treatment will be determined by the medical team based on your specific condition and response to the treatment.

5 monitoring and assessments

Throughout the trial, your health will be closely monitored. This includes checking your vital signs, conducting laboratory tests, and performing imaging studies to assess your response to the treatment.

Your progress will be evaluated at various points, including 7 to 10 days after the VAP diagnosis and at day 28.

6 follow-up

Your vital status will be assessed at day 28 and day 90. This involves checking your overall health and any changes in your condition.

Additional assessments may include the number of days you are free from mechanical ventilation, the length of your stay in the intensive care unit and hospital, and any new episodes of VAP.

Who Can Join the Study?

  • Must be an adult (18 years or older).
  • Must have been on a breathing machine (mechanical ventilation) for at least five days.
  • Must have a confirmed diagnosis of ventilator-associated pneumonia (VAP) through a test, preferably from a sample taken deep in the lungs. If not possible, a sample from the windpipe is acceptable.
  • The infection must be caused by bacteria called Enterobacteriaceae that can be treated with the study medication, cotrimoxazole. If there are multiple types of bacteria, all must be treatable with the study medication.
  • Must have been treated with at least one effective antibiotic for 24 to 72 hours before joining the study. If there are multiple types of bacteria, all must be treatable with the initial antibiotics.
  • Must have stable or improving blood pressure and breathing conditions. This means either the same or a reduced need for medications that support blood pressure and either the same or improved oxygen levels in the blood.

Who Cannot Join the Study?

  • Patients who are not in the Intensive Care Unit (ICU). The ICU is a special area in the hospital where very sick patients receive close monitoring and care.
  • Patients who do not have Ventilator-associated Pneumonia (VAP). This is a type of lung infection that can occur in people who are on a ventilator, a machine that helps them breathe.
  • Patients who are not within the specified age range for the study. The study may have specific age requirements.
  • Patients who are not part of the specified clinical trial groups. The study may be looking for participants with certain characteristics or conditions.
  • Patients who are not considered part of a vulnerable population. Vulnerable populations may include groups like children, pregnant women, or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Jean Perrin Clermont Ferrand France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Groupe Hospitalier Du Sud Ile De France Melun France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hopital NOVO Pontoise France
Centre Hospitalier De Cholet Cholet France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Hopital Ambroise Pare Boulogne-Billancourt France
Centre Hospitalier Universitaire De Nantes Saint-Herblain France
Centre Hospitalier De Saint-Denis St Denis France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Hopital Louis Mourier Colombes France
Cobxra Husjskhuaki Ubrzsnailmkhk Dz Dnuyt Dijon France
Ckietv Hvftxsilvnl Ljdv Byfrq Pvvywoa Provins France
Gsnvlh Hskptuhjjtv Nxmp Elosixn Orsay France
Cty dvlynouvflghfz Epagny Metz Tessy France
Awbxteaweh Pgqqyart Hkgujvtp De Pyhuv Paris France
Cfspzk Hejehnzpqjr Rdkftlcs Uzunfclxsejaq Ds Tlpcx Tours France
Cokj Dc Nglis Vandoeuvre Les Nancy France
Csxgnz Hhpnasgknvt Ramcbxet Dtyjhpethdyxhu Angers France
Uaytfxlter Hkwuvflbd Pxgyg Ssajjrscezn Ckkemjq Fmtu Paris France
Iuzqmvzd dk Cztuhvlzbbus Hdsyihltuzj Urqivdzmlpmje dw Sdaug Ewdvgrh (evyvbeg Saint Priest En Jarez France

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.09.2023

Trial locations

Investigated drugs:

Cotrimoxazole is a combination of two antibiotics, sulfamethoxazole and trimethoprim, that work together to treat bacterial infections. In this clinical trial, it is being tested to see if it is as effective as the best standard treatments currently used for treating Ventilator-Associated Pneumonia (VAP) in patients in intensive care units. The goal is to determine if cotrimoxazole can be a reliable option for treating this type of pneumonia, which occurs in patients who are on mechanical ventilation.

Ventilator-associated Pneumonia – Ventilator-associated Pneumonia is a lung infection that occurs in people who are on mechanical ventilation breathing machines in hospitals. It typically develops 48 hours or more after mechanical ventilation is initiated. The disease is characterized by inflammation of the lung tissue due to bacterial infection. Patients may experience symptoms such as fever, increased white blood cell count, and purulent sputum. The progression involves the accumulation of fluid and pus in the alveoli, leading to impaired gas exchange. If not managed, it can lead to further complications, including respiratory distress.

Trial ID:
2023-505108-52-00
Protocol code:
APHP220799
NCT ID:
NCT05696093
Trial Phase:
Therapeutic confirmatory (Phase III)

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