Study on Antibiotic Treatments for Kidney Infection in Children: Comparing Cefixime, Ceftriaxone, and Amikacin for Ages 1 Month to 3 Years

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What is this study about?

This clinical trial is focused on studying the treatment of acute pyelonephritis in children aged 1 month to 3 years. Acute pyelonephritis is a type of kidney infection that can cause symptoms like fever and pain. The study will compare two different treatment approaches using antibiotics. One group will receive a 3-day course of intravenous (IV) antibiotics, while the other group will receive the same 3-day IV treatment followed by a 7-day course of oral antibiotics. The antibiotics being studied include ceftriaxone, amikacin, cefixime, and a combination of sulfamethoxazole and trimethoprim.

The purpose of the study is to determine if the shorter IV-only treatment is as effective as the longer treatment that includes oral antibiotics. The study will monitor the occurrence of kidney scarring, which is a potential complication of the infection, to see if there is any difference between the two treatment methods. Participants will be observed over a period of time, with follow-up checks to assess their recovery and any potential side effects.

Throughout the study, children will be closely monitored for signs of recovery, such as the absence of fever, abdominal pain, and feeding problems. The study will also check for any recurrence of infection and monitor for the presence of antibiotic-resistant bacteria. The trial aims to provide valuable information on the best treatment approach for young children with acute pyelonephritis, ensuring effective care and minimizing potential complications.

1 initial treatment

The treatment begins with a 3-day intravenous (IV) antibiotic therapy. The antibiotics used are ceftriaxone and/or amikacin. These are administered as a solution for injection.

This phase is crucial for addressing the acute symptoms of the condition.

2 randomization

After the initial 3-day IV treatment, the next step involves randomization. This means that the treatment plan is determined by chance, similar to flipping a coin.

The purpose of randomization is to compare two different treatment approaches objectively.

3 follow-up treatment

Depending on the randomization outcome, the treatment may continue with a 7-day oral antibiotic therapy using cefixime or sulfamethoxazole and trimethoprim. These are taken by mouth.

The goal is to evaluate if the additional oral treatment is necessary for preventing complications.

4 monitoring and evaluation

Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment. This includes checking for clinical cure at the end of the antibiotic treatment, which is defined by the absence of fever, abdominal pain, and feeding problems.

Additional evaluations include checking for recurrent infections within 90 days and monitoring for any colonization with resistant bacteria.

5 final assessment

The primary endpoint is assessed at 6 months after the start of therapy. This involves a specialized scan to check for any kidney scarring.

The results of this assessment help determine the long-term effectiveness of the treatment strategies.

Who Can Join the Study?

Children must be at least 1 month old and younger than 3 years old. For children younger than 3 months, they must have been born after 34 weeks of pregnancy.
The child must be experiencing their first episode of a urinary tract infection.
The child must have acute pyelonephritis (AP), which is a type of kidney infection. This is defined by having a fever of at least 38°C on the day of diagnosis and a positive urine test showing white blood cells of at least 104/mL.
The initial treatment must include either ceftriaxone or amikacin, which are types of antibiotics.
The child can be treated as an outpatient (not staying in the hospital) or be hospitalized.

Who Cannot Join the Study?

Children who have a different kidney infection that is not acute pyelonephritis (AP). AP is a sudden and severe kidney infection.
Children who are younger than 2 years old.
Children who have other serious health conditions that might affect the study.
Children who are allergic to the antibiotics used in the study.
Children who have already been treated with antibiotics for this infection before joining the study.
Children who have a history of kidney problems that are not related to the current infection.
Children who are unable to take oral medication after the initial treatment.
Children who are part of another clinical trial at the same time.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nantes	Nantes	France
Gmtzex Hkgcwpnxipn Nzjf Emzewkl	Orsay	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	22.03.2023

Trial locations

Investigated drugs:

Intravenous Antibiotic Therapy
This treatment involves administering antibiotics directly into the bloodstream through an IV. It is used to quickly deliver medication to treat infections, such as acute pyelonephritis, in children. The trial is testing a 3-day course of this therapy to see if it is effective in preventing renal scarring.

Oral Antibiotic Therapy
This treatment involves taking antibiotics by mouth in the form of tablets or liquid. In the trial, this therapy is given for 7 days following an initial 3-day intravenous antibiotic treatment. The goal is to determine if this combination is as effective as the intravenous therapy alone in treating acute pyelonephritis in children.

Investigated diseases:

Pyelonephritis acute

Acute Pyelonephritis in Children – Acute pyelonephritis is a sudden and severe kidney infection that primarily affects children. It occurs when bacteria travel from the bladder to the kidneys, causing inflammation and infection. Symptoms often include high fever, abdominal or back pain, and frequent urination. If not addressed, the infection can lead to complications such as kidney damage. The condition typically requires prompt medical attention to prevent further issues. It is more common in girls than boys and can recur if not properly managed.

Trial ID:

2024-518930-10-00

Protocol code:

APHP211043

NCT ID:

NCT05544565

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Antibiotic Treatments for Kidney Infection in Children: Comparing Cefixime, Ceftriaxone, and Amikacin for Ages 1 Month to 3 Years

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?