EFFICIENCY OF PHOSPHOMYCIN FOR CYSTITIS TREATMENT IN PEDIATRIC AGE

Phase 1

• Conditions: acute cystitis; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-001017-16-ES
• Lead Sponsor: Hospital Dr Josep Trueta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-26
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 98

Inclusion Criteria

Children between 2 and 14 years of age, who are continents, with clinical suspicion of acute cystitis (any combination of dysuria, frequency, urgency and urgency) and who present any of the following alterations in the initial urinalysis:
- Urine strip with presence of nitrites.
- Urine strip with presence of leukocytes (leukocyte esterase) greater than or equal to a cross (X).
- Gram staining: presence of moderate bacteriuria ( 1 microorganism per field) in a drop of urine without centrifuging with 100-magnification objective.
Subsequently, at 72 hours, the diagnosis of acute cystitis must be confirmed by obtaining the positive result of the quantitative urine culture taken on the day of the visit, and must comply with:
-> 50,000 Colony Forming Units (CFU) / mL of a single germ obtained by spontaneous urination.
Are the trial subjects under 18? yes
Number of subjects for this age range: 98
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Children with the diagnosis of acute cystitis under 2 years or over 14 years of age.
- Children not continents.
- Immunosuppressed patients.
- Clinic suggestive of acute pyelonephritis (lumbar pain, fever=38ºC and / or general condition and / or analytical involvement with CRP> 2mg / dL or PCT> 1ng / mL).
- Uropathy or known nephropathy.
- Have received antibiotic treatment the previous 2 weeks.
- Hypersensitivity to fosfomycin, cefuroxime-axetil to beta-lactams, or hypersensitivity to any of its components.
- Patient carrying a bladder catheter.
- Presence of other accompanying infections at the time of diagnosis of acute cystitis.
- Patient withany type of chronic disease (neurological, cardiac, endocrine ...) uncompensated
- Patient who uses chronic medication with corticosteroids or biological medications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified