Acute Urinary Tract InfectionPhase 3STARRSNCT01391793

Corticosteroids for Children With Febrile Urinary Tract Infections

A Phase 3 study testing Dexamethasone in people with Acute Urinary Tract Infection and Urinary Tract Infection, run by Nader Shaikh at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys. Read more about this study

Who is it for?: Ages 2 months to 6 years
Conditions the study is for: Acute Urinary Tract Infection, Urinary Tract Infection
What is being tested?: Dexamethasone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 546 participants
Where: 6 sitesUnited States
Study dates: Sep 2011to 30 Mar 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 months to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age: 2 months to 6 years
Pyuria: ≥10 white blood cells per cubic millimeter (WBC/mm3) in an uncentrifuged specimen or ≥5 white blood cells per high power field (WBC/hpf) in a centrifuged specimen or ≥1+ leukocyte esterase (LE) on dipstick
Fever: documented temperature of at least 101 °F or 38.3°C, measured anywhere on the body either at home or at doctor's office within 24 hours of diagnosis

Who cannot join

Other concurrent systemic bacterial infection(s) such as meningitis or pneumonia;
Planned admission to intensive care unit;
Known bacteremia;
Previous protocol defined UTI;
Known major urinary tract anomalies (severe hydronephrosis, ureterocele, urethral valve, solitary or profoundly small kidney, multicystic dysplastic kidney, neurogenic bladder, pelvic or fused kidney);
Congenital/acquired immunodeficiency;

Show all 13Show fewer

Bag urine collection
Chronic diseases that could potentially interfere with response to therapy, such as chronic gastrointestinal conditions (i.e. malabsorption, inflammatory bowel disease), liver/kidney failure;
Allergy to dexamethasone
Antibiotic use within 7 days of enrollment (except if given in the last 48 hours)
Systemic use of corticosteroids or other immunomodulating agents within 14 days of enrollment
History of Kawasaki disease
Sickle cell disease (not trait)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Nationwide Children's Hospital in Columbus
Columbus, Ohio, 43205
American Family Children's Hospital
Madison, Wisconsin, 53792
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Primary Children's Hospital
Salt Lake City, Utah, 84113
Children's National Medical Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.

Read the detailed description

Because host inflammatory response is the final and most important step in the formation of renal scars, the use of anti-inflammatory agents may be the best strategy to reduce renal scarring. In animal studies, the use of corticosteroids has been shown to be effective in preventing post-pyelonephritic scarring. We will conduct a randomized, double-blind, placebo-controlled trial to determine the efficacy of 3 days of daily adjuvant dexamethasone on the incidence of renal scarring 4 to 6 months after a first febrile urinary tract infection (UTI). We hypothesize that the proportion of children with UTI who develop renal scarring will be lower among children who are treated with both dexamethasone and antibiotics as compared with children treated with antibiotics alone.

Conditions: Acute Urinary Tract Infection, Urinary Tract Infection
Being tested: Placebo, Dexamethasone
Keywords: Renal scarring, Dexamethasone, Child, Corticosteroids, Pediatric, Urinary tract infection, Escherichia Coli Urinary Tract Infection
Medical subject headings: Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Also called Inactive medicine
Twice daily for 3 days
DexamethasoneDrug
Also called Prelone, Orapred, Corticosteroid
0.15 mg/kg/dose twice daily for 3 days

Study groups in NCT01391793
Study group	Role	What they receive
Adjuvant dexamethasone	Active comparator	Not described Receives: Drug: Dexamethasone
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan
Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with scarring by the majority of readers, then the child was determined to have renal scarring.
Measured: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.
The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan
Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Scarring was assessed semi-quantitatively by dividing the renal cortex into 12 equal segments. Severe scarring was defined as greater than 4 affected renal segments or global atrophy, i.e. diffuse scarring or shrunken kidney. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of severe scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with severe scarring by the majority of readers, then the child was determined to have severe renal scarring.
Measured: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.

Secondary outcomes (1)

The Mean Proportion of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Taken Across the 3 Radiologists
Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For each radiologist, for each child, if either kidney or both kidneys were diagnosed with scarring, then the child was determined to have renal scarring. For each radiologist, the proportion of children with scarring in a given treatment group is the number of children diagnosed with scarring divided by the number of children in the treatment group. The mean proportion of children with scarring in a given treatment group is the average proportion taken across the 3 radiologists.
Measured: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201130 Mar 2018

First posted12 Jul 2011 (estimated)
Study startSep 2011
Primary completion30 Mar 2018
Study completion30 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute Urinary Tract InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 546 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01391793
Sponsor's protocol ID: R01DK087870
Other IDs: R01DK087870
Acronym: STARRS
Status last verified: Jun 2019
First submitted: 8 Jul 2011
Last updated: 2 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Shaikh N, Liu H, Kurs-Lasky M, Forster CS. Biomarkers for febrile urinary tract infection in children. Pediatr Nephrol. 2022 Jan;37(1):171-177. doi: 10.1007/s00467-021-05173-x. Epub 2021 Jul 12.
PubMed 34251495
Shaikh N, Shope TR, Hoberman A, Muniz GB, Bhatnagar S, Nowalk A, Hickey RW, Michaels MG, Kearney D, Rockette HE, Charron M, Lim R, Majd M, Shalaby-Rana E, Kurs-Lasky M, Cohen DM, Wald ER, Lockhart G, Pohl HG, Martin JM. Corticosteroids to prevent kidney scarring in children with a febrile urinary tract infection: a randomized trial. Pediatr Nephrol. 2020 Nov;35(11):2113-2120. doi: 10.1007/s00467-020-04622-3. Epub 2020 Jun 15.
PubMed 32556960

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
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All Acute Urinary Tract Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Corticosteroids for Children With Febrile Urinary Tract Infections
ClinicalTrials.gov ID: NCT01391793
Acronym / sponsor ID: STARRS / R01DK087870
Conditions: Acute Urinary Tract Infection, Urinary Tract Infection
Keywords: Renal scarring, Dexamethasone, Child, Corticosteroids, Pediatric, Urinary tract infection, Escherichia Coli Urinary Tract Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 546 participants (actual)
Lead sponsor: Nader ShaikhUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Sep 2011
Primary completion: 30 Mar 2018 (actual)
Study completion: 30 Mar 2018 (actual)
First posted: 12 Jul 2011 (estimated)
Results: Posted 2 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Adjuvant dexamethasone	Active comparator	Drug: Dexamethasone
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 2 months to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Age: 2 months to 6 years
Pyuria: ≥10 white blood cells per cubic millimeter (WBC/mm3) in an uncentrifuged specimen or ≥5 white blood cells per high power field (WBC/hpf) in a centrifuged specimen or ≥1+ leukocyte esterase (LE) on dipstick
Fever: documented temperature of at least 101 °F or 38.3°C, measured anywhere on the body either at home or at doctor's office within 24 hours of diagnosis

Key exclusion criteria (13 listed)

Other concurrent systemic bacterial infection(s) such as meningitis or pneumonia;
Planned admission to intensive care unit;
Known bacteremia;
Previous protocol defined UTI;
Known major urinary tract anomalies (severe hydronephrosis, ureterocele, urethral valve, solitary or profoundly small kidney, multicystic dysplastic kidney, neurogenic bladder, pelvic or fused kidney);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboAlso: Inactive medicineTwice daily for 3 days	Drug	Placebo
DexamethasoneAlso: Prelone, Orapred, Corticosteroid0.15 mg/kg/dose twice daily for 3 days	Drug	Adjuvant dexamethasone

Primary outcome

The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan
Time frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.
Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with scarring by the majority of readers, then the child was determined to have renal scarring.
The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan
Time frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.
Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Scarring was assessed semi-quantitatively by dividing the renal cortex into 12 equal segments. Severe scarring was defined as greater than 4 affected renal segments or global atrophy, i.e. diffuse scarring or shrunken kidney. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of severe scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with severe scarring by the majority of readers, then the child was determined to have severe renal scarring.

1 secondary outcome

The Mean Proportion of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Taken Across the 3 Radiologists
Time frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.

Results and safety

Results posted to the registry on 2 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adjuvant Dexamethasone	271	124
Placebo	275	131

Primary outcome: The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan

Time frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.. Count of participants. Unit: Participants

Measure	Adjuvant Dexamethasone n = 123	Placebo n = 131
With scarring	12	22
Without scarring	111	109

Adjuvant Dexamethasone vs Placebo: p = 0.16, Regression, Logistic

Population analysed: The analysis was Intent-to-Treat (ITT). The number of participants is equal to the number of children randomized and eligible who had a positive urine culture at enrollment and a DMSA renal scan, of adequate quality, 5-24 months from the time of enrollment.

Primary outcome: The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan

Time frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.. Count of participants. Unit: Participants

Measure	Adjuvant Dexamethasone n = 123	Placebo n = 131
With severe scarring	0	3
Without severe scarring	123	128

Adjuvant Dexamethasone vs Placebo: p = 0.25, Test of equality - 2 Poisson parameters

Population analysed: The analysis was ITT. The number of participants is equal to the number of children randomized and eligible who had a positive urine culture at enrollment and a DMSA renal scan, of adequate quality, 5-24 months from the time of enrollment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adjuvant Dexamethasone	9 of 271 (3.3%)	68 of 271 (25.1%)	0 of 271
Placebo	9 of 275 (3.3%)	52 of 275 (18.9%)	0 of 275

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34251495Shaikh N, Liu H, Kurs-Lasky M, Forster CS. Biomarkers for febrile urinary tract infection in children. Pediatr Nephrol. 2022 Jan;37(1):171-177. doi: 10.1007/s00467-021-05173-x. Epub 2021 Jul 12.
Derived from this study: PubMed 32556960Shaikh N, Shope TR, Hoberman A, Muniz GB, Bhatnagar S, Nowalk A, Hickey RW, Michaels MG, Kearney D, Rockette HE, Charron M, Lim R, Majd M, Shalaby-Rana E, Kurs-Lasky M, Cohen DM, Wald ER, Lockhart G, Pohl HG, Martin JM. Corticosteroids to prevent kidney scarring in children with a febrile urinary tract infection: a randomized trial. Pediatr Nephrol. 2020 Nov;35(11):2113-2120. doi: 10.1007/s00467-020-04622-3. Epub 2020 Jun 15.
Individual participant dataSharing planned: No

Related trials for Acute Urinary Tract Infection

Not yet recruiting
Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity
Children With Medical Complexity, Respiratory Tract Infections (RTI)
Not yet recruitingPhase 2
This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis
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RecruitingPhase 2
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nader Shaikh, MD principal investigator

University of Pittsburgh

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone in people with Acute Urinary Tract Infection and Urinary Tract Infection, run by Nader Shaikh at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan (time frame: The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01391793, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.