Urinary Tract InfectionNCT07204769
Microbiological Characterization and Antibiotic Resistance Profiling of Providencia Spp,: An Emerging Pathogen Isolated From Urinary Tract Infections
An observational study of Urinary Tract Infection, run by Assiut University at 1 site in Egypt.
Trial summary
Aims of the Research: 1. Isolation and identification of Providencia spp. from UTIs. 2. Genotypic confirmation of Providencia isolates. 3. Determination of antimicrobial sensitivity patterns of isolated Providencia spp. 4. Characterization of some virulence factors of Providencia spp. 5. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Antibiotic sensitivity
- How many people
- 241 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with UTI diagnosed through clinical examination and urine analysis.
Who may be able to join
- Patients with UTI diagnosed through clinical examination and urine analysis. Informed consent will be obtained from each patient before Participation in the study.
Who cannot join
- Patients currently on antibiotics.
- Patients with any anatomical abnormalities in the urinary tract C) Patients having UTI by gram +ve organisms.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Microbiological Characterization and Antibiotic Resistance Profiling of Providencia Spp,: An Emerging Pathogen Isolated From Urinary Tract Infections.
Aims of the Research:
- Isolation and identification of Providencia spp. from UTIs.
- Genotypic confirmation of Providencia isolates.
- Determination of antimicrobial sensitivity patterns of isolated Providencia spp.
- Characterization of some virulence factors of Providencia spp.
- Molecular characterization of multidrug-resistance gene antibiotics.
- Determination of risk factors for Providencia UTIs.
Read the detailed description
Urinary tract infections (UTIs) are among the most common bacterial infections worldwide, with Escherichia coli, Klebsiella spp., Proteus spp., and Pseudomonas spp. representing the majority of isolated pathogens in both community and hospital settings. Providencia spp., although historically considered uncommon, are increasingly recognized as opportunistic pathogens.
International surveillance studies report that Providencia accounts for ~1-2% of urinary isolates, with higher prevalence (up to 6-12%) in catheter-associated infection.
The Providencia genus, nestled within the Enterobacterales order as part of Proteus and Morganella relatives, consists of Gram-negative bacteria that are adept at producing urease .
The genus includes 14 distinct species, with Providencia rettgeri, Providencia stuartii, Providencia alcalifaciens, and Providencia hangzhouensis standing out due to their pronounced relevance to human infections. Renowned for their association with urinary tract infections, these pathogens also possess the capability to inflict a broader spectrum of severe ailments, such as ocular diseases,peritonitis, neonatal septicemia or bloodstream infections and meningitis.
Providencia stuartii is able to adhere to and invade HeLa-M epithelial cell line.
They form biofilms and have several virulence genes . Providencia spp. may be susceptible to third- and fourth-generation cephalosporins, aztreonam, imipenem, and meropenem. Providencia species have variable susceptibilities to fluoroquinolones, aminoglycosides, and trimethoprim- sulfamethoxazole (TMP-SMX). Generally, Providencia spp. are frequently resistant to tetracyclines, penicillins, and first- and second- generation cephalosporins .
Providencia spp.are intrinsically resistant to polymyxins and tigecycline, which are considered last- resort antibiotics for other resistant pathogens .
In Egypt, several studies have investigated the prevalence of UTI pathogens, consistently reporting E. coli, Klebsiella spp., and Proteus spp. as the most frequent isolates .
However, no published Egyptian data specifically describe the prevalence, antimicrobial resistance patterns, or clinical significance of Providencia spp. in UTIs.
This gap highlights the need for focused research on Providencia in the Egyptian context. Studying its frequency, antibiotic resistance mechanisms, and clinical relevance would not only provide novel insights but also contribute to improving diagnosis, empirical therapy, and infection control strategies in Egyptian hospitals .
- Conditions
- Urinary Tract Infection
- Being tested
- Antibiotic sensitivity
- 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.
Antibiotic sensitivityDrug
Molecular characterization of multidrug-resistance gene antibiotics.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of prevalence of Providencia species refers specifically to urinary tract infection patients with gram-negative bacterial isolates.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 May 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Tareq Diab, Assiut University
- Investigators
- Aya Tareq Diab, Bachelor's degree, Principal investigator, Assiut UniversityProf: Mona Hussein Abdel-Rahim, PhD, Study director, Assiut UniversityDr. Rawhia Fathy Abdel Hamid, Doctorate, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204769
- Sponsor's protocol ID
- Providencia UTI
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Çetin ET, et al. Providencia spp. in nosocomial urinary infections. Turk J Med Sci. 1998;28(1):59-62
Ewing WH. The tribe Proteeae: its nomenclature and taxonomy. Int J Syst Evol Microbiol. 1962;12(3):93-102
Charbek EPN. Providencia infections treatment & management: medical care, surgical care, consultations. Medscape. 2019
Rose WE, Rybak MJ. Tigecycline: first of a new class of antimicrobial agents. Pharmacotherapy. 2006 Aug;26(8):1099-110. doi: 10.1592/phco.26.8.1099.
PubMed 16863487Guidone GHM, Cardozo JG, Silva LC, Sanches MS, Galhardi LCF, Kobayashi RKT, Vespero EC, Rocha SPD. Epidemiology and characterization of Providencia stuartii isolated from hospitalized patients in southern Brazil: a possible emerging pathogen. Access Microbiol. 2023 Oct 18;5(10):000652.v4. doi: 10.1099/acmi.0.000652.v4. eCollection 2023.
PubMed 37970084Kurmasheva N, Vorobiev V, Sharipova M, Efremova T, Mardanova A. The Potential Virulence Factors of Providencia stuartii: Motility, Adherence, and Invasion. Biomed Res Int. 2018 Feb 21;2018:3589135. doi: 10.1155/2018/3589135. eCollection 2018.
PubMed 29682537Dong X, Xiang Y, Yang P, Wang S, Yan W, Yuan Y, Zhou S, Zhou K, Liu J, Zhang Y. Novel Providencia xianensis sp. nov.: A multidrug-resistant species identified in clinical infections. Eur J Clin Microbiol Infect Dis. 2024 Jul;43(7):1461-1467. doi: 10.1007/s10096-024-04821-y. Epub 2024 May 7.
PubMed 38714595O'Hara CM, Brenner FW, Miller JM. Classification, identification, and clinical significance of Proteus, Providencia, and Morganella. Clin Microbiol Rev. 2000 Oct;13(4):534-46. doi: 10.1128/CMR.13.4.534.
PubMed 11023955Wie SH. Clinical significance of Providencia bacteremia or bacteriuria. Korean J Intern Med. 2015 Mar;30(2):167-9. doi: 10.3904/kjim.2015.30.2.167. Epub 2015 Feb 27. No abstract available.
PubMed 25750557
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Characterization and Antibiotic Resistance Profiling of Providencia Spp,: An Emerging Pathogen Isolated From Urinary Tract Infections.
- ClinicalTrials.gov ID
- NCT07204769
- Acronym / sponsor ID
- Providencia UTI
- Conditions
- Urinary Tract Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims of the Research:
- Isolation and identification of Providencia spp. from UTIs.
- Genotypic confirmation of Providencia isolates.
- Determination of antimicrobial sensitivity patterns of isolated Providencia spp.
- Characterization of some virulence factors of Providencia spp.
- Molecular characterization of multidrug-resistance gene antibiotics.
- Determination of risk factors for Providencia UTIs.
Detailed description
Urinary tract infections (UTIs) are among the most common bacterial infections worldwide, with Escherichia coli, Klebsiella spp., Proteus spp., and Pseudomonas spp. representing the majority of isolated pathogens in both community and hospital settings. Providencia spp., although historically considered uncommon, are increasingly recognized as opportunistic pathogens.
International surveillance studies report that Providencia accounts for ~1-2% of urinary isolates, with higher prevalence (up to 6-12%) in catheter-associated infection.
The Providencia genus, nestled within the Enterobacterales order as part of Proteus and Morganella relatives, consists of Gram-negative bacteria that are adept at producing urease .
The genus includes 14 distinct species, with Providencia rettgeri, Providencia stuartii, Providencia alcalifaciens, and Providencia hangzhouensis standing out due to their pronounced relevance to human infections. Renowned for their association with urinary tract infections, these pathogens also possess the capability to inflict a broader spectrum of severe ailments, such as ocular diseases,peritonitis, neonatal septicemia or bloodstream infections and meningitis.
Providencia stuartii is able to adhere to and invade HeLa-M epithelial cell line.
They form biofilms and have several virulence genes . Providencia spp. may be susceptible to third- and fourth-generation cephalosporins, aztreonam, imipenem, and meropenem. Providencia species have variable susceptibilities to fluoroquinolones, aminoglycosides, and trimethoprim- sulfamethoxazole (TMP-SMX). Generally, Providencia spp. are frequently resistant to tetracyclines, penicillins, and first- and second- generation cephalosporins .
Providencia spp.are intrinsically resistant to polymyxins and tigecycline, which are considered last- resort antibiotics for other resistant pathogens .
In Egypt, several studies have investigated the prevalence of UTI pathogens, consistently reporting E. coli, Klebsiella spp., and Proteus spp. as the most frequent isolates .
However, no published Egyptian data specifically describe the prevalence, antimicrobial resistance patterns, or clinical significance of Providencia spp. in UTIs.
This gap highlights the need for focused research on Providencia in the Egyptian context. Studying its frequency, antibiotic resistance mechanisms, and clinical relevance would not only provide novel insights but also contribute to improving diagnosis, empirical therapy, and infection control strategies in Egyptian hospitals .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with UTI diagnosed through clinical examination and urine analysis.
Key inclusion criteria (1 listed)
- Patients with UTI diagnosed through clinical examination and urine analysis. Informed consent will be obtained from each patient before Participation in the study.
Key exclusion criteria (2 listed)
- Patients currently on antibiotics.
- Patients with any anatomical abnormalities in the urinary tract C) Patients having UTI by gram +ve organisms.
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 |
|---|---|---|
| Antibiotic sensitivityMolecular characterization of multidrug-resistance gene antibiotics. | Drug | – |
Primary outcome
Determination of prevalence of Providencia species refers specifically to urinary tract infection patients with gram-negative bacterial isolates.
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Results publicationÇetin ET, et al. Providencia spp. in nosocomial urinary infections. Turk J Med Sci. 1998;28(1):59-62
- Results publicationEwing WH. The tribe Proteeae: its nomenclature and taxonomy. Int J Syst Evol Microbiol. 1962;12(3):93-102
- Results publicationCharbek EPN. Providencia infections treatment & management: medical care, surgical care, consultations. Medscape. 2019
- Results publication: PubMed 16863487Rose WE, Rybak MJ. Tigecycline: first of a new class of antimicrobial agents. Pharmacotherapy. 2006 Aug;26(8):1099-110. doi: 10.1592/phco.26.8.1099.
- Results publication: PubMed 37970084Guidone GHM, Cardozo JG, Silva LC, Sanches MS, Galhardi LCF, Kobayashi RKT, Vespero EC, Rocha SPD. Epidemiology and characterization of Providencia stuartii isolated from hospitalized patients in southern Brazil: a possible emerging pathogen. Access Microbiol. 2023 Oct 18;5(10):000652.v4. doi: 10.1099/acmi.0.000652.v4. eCollection 2023.
- Results publication: PubMed 29682537Kurmasheva N, Vorobiev V, Sharipova M, Efremova T, Mardanova A. The Potential Virulence Factors of Providencia stuartii: Motility, Adherence, and Invasion. Biomed Res Int. 2018 Feb 21;2018:3589135. doi: 10.1155/2018/3589135. eCollection 2018.
- Results publication: PubMed 38714595Dong X, Xiang Y, Yang P, Wang S, Yan W, Yuan Y, Zhou S, Zhou K, Liu J, Zhang Y. Novel Providencia xianensis sp. nov.: A multidrug-resistant species identified in clinical infections. Eur J Clin Microbiol Infect Dis. 2024 Jul;43(7):1461-1467. doi: 10.1007/s10096-024-04821-y. Epub 2024 May 7.
- Results publication: PubMed 11023955O'Hara CM, Brenner FW, Miller JM. Classification, identification, and clinical significance of Proteus, Providencia, and Morganella. Clin Microbiol Rev. 2000 Oct;13(4):534-46. doi: 10.1128/CMR.13.4.534.
- Results publication: PubMed 25750557Wie SH. Clinical significance of Providencia bacteremia or bacteriuria. Korean J Intern Med. 2015 Mar;30(2):167-9. doi: 10.3904/kjim.2015.30.2.167. Epub 2015 Feb 27. No abstract available.
- Individual participant dataSharing planned: No
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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.
Aya Tareq Diab, Bachelor's degree principal investigator
Assiut University
Prof: Mona Hussein Abdel-Rahim, PhD study director
Assiut University
Dr. Rawhia Fathy Abdel Hamid, Doctorate study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Tareq Diab, Bachelor's degree (+201157456012, ay39090ta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of prevalence of Providencia species refers specifically to urinary tract infection patients with gram-negative bacterial isolates. (time frame: Through study completion, an average of 1 year). 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 NCT07204769, which also lists 9 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 Oct 2025.