Not yet recruiting

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

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

5 criteria

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 trial?

8 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier De Roubaix
Roubaix, France
Verified
Centre Hospitalier Universitaire De Nantes
Nantes, France
Verified
Groupe Hospitalier Nord Essonne
Orsay, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

Antibiotic Therapy – This medication is administered intravenously and orally, depending on the treatment phase. It is currently being studied in clinical trials to determine its effectiveness in treating acute pyelonephritis in children aged 1 month to 3 years. The main therapeutic indication is to treat bacterial infections in the kidneys. The mechanism of action involves inhibiting bacterial cell wall synthesis, leading to the destruction of the bacteria. It is classified as an antibiotic, specifically targeting bacterial infections.

Investigated diseases

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.