acute cystitis
Conditions
Interventions
Trade Name: FOSFOMICINA CALCICA SOLUFOS
Pharmaceutical Form: Pour-on solution
INN or Proposed INN: FOSFOMYCIN
CAS Number: 23155-02-4
Con
Sponsors
Hospital Dr Josep Trueta
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine that fosfomycin (administered in any of its formulas) is not inferior to cefuroxime - axetil in the negativeization of the urine culture 72 hours after initiating the treatment of acute cystitis.; Secondary Objective: • To determine that the clinical efficacy of fosfomycin is not inferior to cefuroxime - axetil 72 hours after starting treatment. • Know the percentage of patients with a new episode of UTI during the first month after acute cystitis. • See what is the tolerance, adherence and adverse events of the antibiotics used ;Primary end point(s): Microbiological eradication: defined as negative urocultive (<50,000 CFU / mL) in control urine culture 72 hours after starting treatment.;Timepoint(s) of evaluation of this end point: 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 72 hours; Secondary end point(s): - Clinical efficacy 72 hours after starting study treatment defined as (3 or more of the following): decrease in abdominal pain more than three points, absence of voiding discomfort, reduction in frequency greater than 50%, absence of vomiting and / or absence of voiding urgency. - Presence of adverse effects at the end of antibiotic treatment with oral fosfomycin or oral cefuroximexetil. Adverse effects such as: Fosfomycin: o Visual alterations, anorexia, phlebitis, dyspnea, bronchospasm and headache. o Hypersensitivity reactions such as: rash, urticaria, angioedema and anaphylaxis. o Vomiting, diarrhea, dyspepsia and nausea. Cefuroxime: o Fungal infection. o Headache and dizziness. o Diarrhea, vomiting, nausea and abdominal pain. o Hypersensitivity reactions such as: rash, urticaria, angioedema and anaphylaxis. or conjunctival jaundice and acute hepatitis. | — |
Countries
Spain
Contacts
Public ContactCristina Martinez
Hospital dr Josep Trueta
Outcome results
None listed