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A Randomized, Controlled Trial of Prulifloxacin as Switched Therapy after Intravenous Carbapenem in The Treatment of Acute Pyelonephritis Caused by Third Generation Cephalosporin Resistant Pathogens: A Pilot study

A Randomized, Controlled Trial of Prulifloxacin as Switched Therapy after Intravenous Carbapenem in The Treatment of Acute Pyelonephritis Caused by Third Generation Cephalosporin Resistant Pathogens: A Pilot study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20181202002
Enrollment
30
Registered
2018-12-02
Start date
2015-08-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute pyelonephritis caused by third generation cephalosporin resistant pathogens with or without bacteremia/sepsis prulifloxacin, ertapenem, pyelonephritis, extended-spectrum beta lactamase

Interventions

Prulifloxacin for switched therapy Dosage and administration 100 mg 4 tab PO OD adjusted dose when Clcr<40 ml/min
Clcr 20&#45
40 ml/min
100 mg 2 tab PO OD ,ertapenem 1 g + 0.9%NSS 50&#45
100 ml IV infusion 30&#45
60 min OD adjusted dose when Clcr<30 ml/min
30 ml/min
500 mg +0.9%NSS 50&#45
60 min OD
Experimental Drug,Experimental Drug
prulifloxacin,Ertapenem

Sponsors

THAI MEIJI PHARMACEUTICAL CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.aged older than 18 years 2.Urine culture show 10,000 CFU/ml of third generation cephalosporin resistant pathogens. Causative bacteria are classified into susceptibility to ertapenem and prulifloxacin. 3.signs and symptoms are not worsening after receiving empirical therapy.

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation 2. History allergy to beta lactams or fluoroquinolones 3. Treatment with antiretroviral drugs, immunosuppressive drugs or corticosteroids 4. Need more than one antibiotic for treatment. 5. Complete obstruction of the urinary tract need to surgery. 6. Serious diseases lead to shorten lifespan no more than 72 hours. 7. Neutropenia (Absolute neutrophil counts less than 500 cell/microliters) 8. Creatinine clearance less than 20 ml/min

Design outcomes

Primary

MeasureTime frame
Overall clinical success (clinical cure and clinical improvement) 1&#45;7 day post treatment (any day) Complete blood count&#44; urine analysis&#44; urine culture&#44; signs and symptoms—

Secondary

MeasureTime frame
Microbiological cure 1&#45;7 day post treatment (any day) urine culture,Recurrent infection 14&#45;30 day post treatment (any day) Complete blood count&#44; urine analysis&#44; urine culture&#44; signs and symptoms—

Countries

Thailand

Contacts

Public ContactApichot So_Ngern

Faculty of pharmacy, Siam University

apichot_songern@hotmail.com0831507749

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026