Trial record 1 of 1 for:    NCT01595529
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The SCOUT Study: Short Course Therapy for Urinary Tract Infections in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Children's Hospital of Philadelphia
Sponsor:
Collaborators:
Children's Hospital of Pittsburgh
University of Pennsylvania
Westat
Information provided by (Responsible Party):
Theoklis Zaoutis, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01595529
First received: May 8, 2012
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

To determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate, defined as symptomatic Urinary Tract Infection (UTI) through Test of Cure (TOC) on Day 11-14, as subjects who continue to take antibiotics for an additional 5 days (standard course therapy). To determine if short-course therapy compared to standard course therapy results in similar numbers of children with gastrointestinal colonization of antimicrobial resistant Escherichia coli (E. coli) and Klebsiella pneumonia (K. pneumoniae).


Condition Intervention Phase
Urinary Tract Infections
Drug: Trimethoprim sulfamethoxazole, amoxicillin-clavulanate, cefixime, or cephalexin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Targeted Clinical Trials to Reduce the Risk of Antimicrobial Resistance The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Occurrence of treatment failures between short-course and standard-course therapies [ Time Frame: 11-14 days following initation of therapy ] [ Designated as safety issue: Yes ]
    Comparison of efficacy, based on symptomatic UTI as assessed up to or at the TOC visit (Day 11-14), between short-course and standard-course therapies.


Secondary Outcome Measures:
  • Occurrence of recurrent infections [ Time Frame: 11-14 days following initation of therapy ] [ Designated as safety issue: Yes ]
    Comparison of number of subjects that have a recurrent infection (includes a relapse UTI or a reinfection) at any time after the TOC visit (Day 11-14), following short-course versus standard-course (of antibiotics.

  • Occurrence of colonization with antimicrobial resistant bacteria [ Time Frame: 24-30 days following initiation of therapy ] [ Designated as safety issue: No ]
    Comparison of the number of subjects that become colonized with antimicrobial resistant Escherichia coli (E .coli) and Klebsiella pneumoniae (K. pneumoniae) in the gastrointestinal tract as assessed through Day 24-30, following short-course versus standard course of antibiotics.

  • Occurrence of asymptomatic bacteriuria [ Time Frame: 11-14 days following initiation of therapy ] [ Designated as safety issue: No ]
    Comparison of the number of subjects with asymptomatic bacteriuria in subjects treated with short-course therapy as compared to the number of subjects treated with standard course therapy at the TOC visit

  • Occurrence of clinical symptoms [ Time Frame: 11-14 days following initiation of therapy ] [ Designated as safety issue: Yes ]
    Comparison of the number of subjects with clinical symptoms that may be related to a UTI in subjects treated with short-course therapy as compared to the number of subjects treated with standard course therapy prior to or at the TOC visit.

  • Occurrence of positive urine cultures [ Time Frame: 11-14 days following initiation of therapy ] [ Designated as safety issue: No ]
    Comparison of the number of subjects with positive urine culture prior to or at TOC between subjects treated with short-course therapy and those treated with standard course therapy.


Estimated Enrollment: 746
Study Start Date: May 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard course (10 days of active antibiotic)
Five days of continued antibiotic following five days of the antibiotic originally prescribed by the patient's treating clinician. Treatments include: 8 mg/kg/day of Trimethoprim in 2 divided doses (Max 160mg BID); 45 mg/kg/day Amoxicillin-clavulanate in 2 divided doses (Max 875 mg Q12H); 8 mg/kg/day cefixime in 1 dose (Max 400 mg); 50mg/kg/day cephalexin in 3 divided doses
Drug: Trimethoprim sulfamethoxazole, amoxicillin-clavulanate, cefixime, or cephalexin
After five days of active drug, five additional days of one of the following: 1) Oral suspension 200 mg of sulfamethoxazole/40 mg trimethoprim per 5mL. 8 mg/kg/day Trimethoprim in 2 divided doses 2) Reconstituted oral suspension 200 mg of amoxicillin/28.5 mg clavulanate potassium per 5 mL for small children or 600 mg of amoxicillin/42.9 mg of clavulanate potassium per 5mL for large children following five days of the originally prescribed dosage of amoxicillin-clavulanate; 3) Reconstituted oral suspension containing 100 mg of cefixime as a trihydrate per 5 mL for small children or 200 mg of cefixime as a trihydrate per 5 mL for large children 4) Reconstituted oral suspension 250mg anhydrous cephalexin per 5mL for small children and two packages of oral suspension of 250mg anhydrous cephalexin per 5mL for large children
Other Names:
  • TMP-SMX
  • Bactrim
  • Augmentin
  • Suprax
  • Keflex
Experimental: Short course (5 days of active antibiotic, 5 days of placebo)
Five days of placebo following five days of the antibiotic originally prescribed by the patient's treating clinician.
Drug: Placebo
After five days of active drug, five days of placebo with the same flavoring as active counterpart. Dosage, dosage form, frequency and duration would be matched to each active counterpart.

Detailed Description:

The standard-of-care to treat uncomplicated UTIs is a 10-day course of antibiotics. Some studies in adults have shown that shorter courses of antibiotics are effective in treating urinary tract infections. The SCOUT Study will determine if five days of antibiotics works as well as 10 days of treatment in children.

In addition, the SCOUT study will determine if the shorter 5-day course of antibiotics is less likely to contribute to antibiotic resistance. The study will try to find out if reducing the antibiotic course to five days of therapy can reduce the chance that antimicrobial resistant bacteria will develop in the gastrointestinal tract. Antibiotics kill the sensitive bacteria but stronger germs may be left to grow and multiply. Antimicrobial resistant bacteria are the bacteria that survive after taking an antibiotic. If these stronger germs grow, the antibiotics may not be as good at killing them.

The study will compare children with urinary tract infections treated with 5 days of antibiotics + five days of placebo (no active medication) versus those treated with 10 full days of antibiotic therapy.

  Eligibility

Ages Eligible for Study:   2 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at randomization: at least two months (at least 36 weeks gestational age for subjects < two years of age) to 10 years of age (120 months)
  • Confirmed UTI diagnosis:

I. At least one of the symptoms consistent with the diagnosis of UTI including:

  • Symptoms for all children (ages two months to 10 years):
  • fever (a documented temperature of at least 100.4 °F OR 38°C measured anywhere on the body)
  • dysuria
  • Children > 2 years of age: suprapubic, abdominal, or flank pain or tenderness, or urinary urgency, frequency, or hesitancy
  • Children ≥ 2 months to 2 years of age: poor feeding or vomiting

AND

II. Pyuria on urinalysis

  • >=10 WBC/mm3 (uncentrifuged specimen) OR
  • >=5 WBC/hpf (centrifuged specimen), OR
  • Leukocyte esterase > trace on dipstick. AND

III. Culture proven infection with a single uropathogen:

  • >=5 x 10^4 CFU/mL (catheterized or suprapubic aspiration urine specimen) OR
  • >=10^5 CFU/mL (clean void specimen).

    • Documented Clinical Improvement at Randomization
    • Afebrile : No documented temperature equal or greater than 100.4 °F or 38°C (measured anywhere on the body) 24 hours prior to the enrollment visit AND
    • Asymptomatic: report NONE of the following symptoms:
    • Only children who have been prescribed one of the four antibiotics for which a placebo is available will be eligible to participate.
    • TMP-SMX
    • Amoxicillin-clavulanate
    • Cefixime
    • Cefdinir
    • Cephalexin (Note a child that received a one-time dose of I.M. or I.V. medication (i.e. in ER or clinic) prior to starting on the one of the four oral medications is eligible for enrollment).
    • Parental/guardian permission (informed consent) and if appropriate, child assent (if > seven years of age).

Exclusion Criteria:

  • A urine culture proven infection with more than one uropathogen of at least 50,000 CFU/mL collected via catheter or suprapubic aspiration OR at least 100,000 CFU/mL collected via clean void.
  • A child hospitalized with a UTI that has the following: concomitant bacteremia associated with the UTI, urosepsis, or is in intensive care.
  • A child whose urine culture reveals an organism that is resistant to the initially prescribed antibiotic.
  • A child with a catheter-associated UTI.
  • A child with known anaphylactic allergies to the study products.
  • A child with phenylketonuria (PKU)
  • A child diagnosed with congenital anomalies of the genitourinary tract
  • UTI in children with known anatomic abnormalities of the genitourinary tract other than VUR, duplicated collection systems, and hydronephrosis.
  • A child that is not able to take oral medications
  • Previous surgery of the genitourinary tract (except circumcision in male children)
  • Presence of an immunocompromising condition (e.g., HIV, malignancy, solid-organ transplant recipients, use of chronic corticosteroids or other immunosuppressive agents).
  • Unlikely to complete follow-up (e.g. not available for the two follow-up study visits and the follow-up phone call)
  • A child with a known history of type I hypersensitivity of the study antibiotics to be prescribed
  • Enrollment in another antibiotic study less than 30 days prior to enrollment visit.
  • Previous enrollment of individuals in this study.
  • Planned enrollment during this study coincides with enrollment in another therapeutic drug study (excluding vaccine).
  • A child with a history of UTI within the past 30 days
  • A child with Grade III-V VUR
  • A child taking antibiotic prophylaxis for any reason.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595529

Contacts
Contact: Theoklis Zaoutis, MD, MSCE 267-426-5570 zaoutis@email.chop.edu
Contact: Shawn O'Connor 267-426-5292 oconnors1@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Theoklis Zaoutis, MD, MSCE         
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Alejandro Hoberman, MD    412-999-3277    hoberman@chp.edu   
Contact: Diana Kearney, CCRC    412-692-6717    diana.kearney@chp.edu   
Principal Investigator: Alejandro Hoberman, MD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Hospital of Pittsburgh
University of Pennsylvania
Westat
Investigators
Principal Investigator: Theoklis Zaoutis, MD, MSCE Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Theoklis Zaoutis, Associate Chief, Division of Infectious Diseases, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01595529     History of Changes
Other Study ID Numbers: 008186, DMID 09-0103
Study First Received: May 8, 2012
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Urinary tract infection
Antibiotic resistance
Short course antibiotics
Pediatrics
Controlled clinical trial
Anti Infective Agents
Trimethoprim Sulfamethoxazole Combination
Cefixime
Amoxicillin-clavulanate
Cephalexin
Trimethoprim-Sulfamethoxazole Combination
Trimethoprim
Sulfamethoxazole
Amoxicillin Potassium Clavulanate Combination
Amoxicillin-Clavulanic Acid

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Cephalexin
Amoxicillin-Potassium Clavulanate Combination
Cefixime
Antibiotics, Antitubercular
Trimethoprim
Sulfamethoxazole
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014