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Compares treatment options for Pyelonephritis Acute
Official title 3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children
ClinicalTrials.gov ID: NCT05544565
What this study is testing
What is IV Antibacterial Agents?
IV Antibacterial Agents is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pyelonephritis acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Antibiotic therapies currently recommended for the treatment of acute pyelonephritis (AP) in children, whether fully by the oral route or initially intravenous (IV, 3 days) followed by the oral route, have a duration of 7 to 14 days (10 days in France). In children with no prior urological malformation, the global clinical and microbiological cure rate after antibiotic treatment completion is around 95%.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 3
You may be able to join if
- Age ≥ 1 month and \< 3 years
- For children younger than 3 months, gestational age \> 34 WA
- First episode of urinary tract infection
- AP defined by temperature ≥ 38°C on day of diagnosis AND positive urinalysis (white cell counts ≥ 10\^4/mL) with a positive urine culture with one...
- Initial treatment by either ceftriaxone AND/OR amikacin
See the full eligibility criteria
- Age ≥ 1 month and \< 3 years
- For children younger than 3 months, gestational age \> 34 WA
- First episode of urinary tract infection
- AP defined by temperature ≥ 38°C on day of diagnosis AND positive urinalysis (white cell counts ≥ 10\^4/mL) with a positive urine culture with one Gram- negative bacillus ≥ 104 UFC/mL. The child temperature will have to...
- Initial treatment by either ceftriaxone AND/OR amikacin
- Outpatient or hospitalised Non-
- Urine collected by bag
- Urine culture growing more than one dominant bacterium (cf section 6.2 of the protocol)
- Catheter-associated acute pyelonephritis
- Known congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation \< 10 mm)
- Previous surgery of the genitourinary tract (except circumcision in male children)
- Abnormal renal function for age and weight (defined by a serum creatinine \>40µmol/L before 1 year and \>75µmol between 1 year et 3 years)
- Known immunocompromising condition (e.g., HIV, primary immunodeficiency, sickle cell disease, use of chronic corticosteroids or other immunosuppressive agents)
- Antibiotic prophylaxis for any reason OR antibiotic treatment in the last 7 days (except treatment administered for the AP)
- Known hypersensitivity to at least one of the active substances /excipients: ceftriaxone (including other cephalosporins and other beta-lactams) and amikacin (including other aminoglycosids).
- Known hypersensitivity to at least one of the active substances /excipients: cotrimoxazole (=sulfamethoxazole/trimethoprim) (including other drugs containing sulfonamides) and cefixime (including other cephalosporins)
- Known blood dyscrasias (megaloblastic haematopoiesis)
- Known severe hepatic insufficiency
- Known G6PD deficiency
- No written consent from holders of parental authority
- Non-affiliation to a social security system (as beneficiary or entitled person)
- Children whose follow-up is not carried out in the centre
- Participation in another treatment or minimal risk trial Randomization criteria :
- Three days of taking antibiotics (IV or IM) (no interruption or discontinuation)
- Positive urine culture with Gram negative bacillus ≥ 10\^4 UFC/mL
- Favorable clinical outcome at day of randomization (D2 or D3) defined by temperature \ 38°C for at least 12 hours AND no abdominal pain AND no feeding problem AND investigator agreement
- No renal abscess AND congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation \< 10 mm) on the renal ultrasound performed between D0 and day of...
- No more than 1 type of dominant bacteria on the urine culture
- Sensitivity to the initial antibiotic treatment
- Sensitivity to cefixime OR cotrimoxazole
The study team makes the final eligibility decision.
Where it's taking place
- Corbeil-Essonnes, Essonne, France
- Orsay, Essonne, France
- Clamart, Haut de Seine, France
- Boulogne, Hauts de Seine, France
- Nantes, Loire Atlantique, France
- Lille, Nord, France
- Paris, Paris, France
- Meaux, Seine et Marne, France
- Bondy, Seine St Denis, France
- Créteil, Val de Marne, France
- Le Kremlin-Bicêtre, Val de Marne, France
- Le Chesnay, Yvelines, France
- Jossigny, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 3 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Corbeil-Essonnes, Essonne, France; Orsay, Essonne, France; Clamart, Haut de Seine, France; Boulogne, Hauts de Seine, France; Nantes, Loire Atlantique, France; Lille, Nord, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.