Urinary Tract InfectionPhase 2NCT03548129
the Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria
A Phase 2 study testing phosphomycin, Culture specific antibiotic therapy and Pre-treatment Urine Culture in people with Urinary Tract Infection, run by Ain Shams University.
Trial summary
Urinary tract infections (UTIs) are the most commonly occurring bacterial infections in women, Asymptomatic bacteriuria (AB) is a common complication during pregnancy, with a prevalence of 2-10%. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- phosphomycin, Culture specific antibiotic therapy and Pre-treatment Urine Culture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients from 13 weeks to 36 weeks gestation.
- Pus cells in urine analysis >5/HPF.
- ≥ 105 colony-forming units (CFU) per millilitre of the same microorganisms in two consecutive cultures.
- No symptoms or sings suggestive of urinary tract infection.
Who cannot join
- Presence of any urinary symptoms as burning micturition, hesitancy
- Fever and loin pain.
- Diabetes mellitus.
- Known to be allergic from any of the antimicrobial ingredients.
- Not using any antimicrobial during the course of treatment for any other infection.
- Not known to have any congenital urinary anomalies.
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- If the patient is taking medications that interact with fosfomycin as:
- Anorexiants (eg, phentermine) or certain sympathomimetics (eg, albuterol, amphetamine, pseudoephedrine) because the risk of their side effects may be increased by fosfomycin.
- Lithium or tetracyclines because their effectiveness may be decreased by fosfomycin.
- Metoclopramide because it may decrease fosfomycin's effectiveness.
- Impaired kidney functions (creatinine's clearance is <80 ml/min.
About this study
Official title: Empirical Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria
Urinary tract infections (UTIs) are the most commonly occurring bacterial infections in women, Asymptomatic bacteriuria (AB) is a common complication during pregnancy, with a prevalence of 2-10%. It has been associated with a greater incidence of symptomatic urinary tract infection (UTI), as well as foetal and obstetric complications. Appropriate treatment reduces the incidence of UTI by 80-90%, as well as the risk of a premature birth and low-birth-weight baby Fosfomycin trometamol (Monuril) is approved in numerous countries worldwide, including various European countries and the USA, mainly for the treatment of uncomplicated UTIs
Read the detailed description
This study aims to compare between the efficacy of empirical use of fosfomycin trometamol and the use of selected antimicrobials according to urinary culture and sensitivity in curing asymptomatic bacteriuria.
All women included in the study will be counseled regarding mode of intervention and informed consent will be obtained. All cases will be subjected to complete history taking, routine antenatal examination and investigations including complete blood picture, kidney functions and urine analysis, treatment of genital infection if diagnosed. Routine obstetric ultrasound examination.
Patients will be randomized into two groups:
- Group (A): Fosfomycin group (FG); where all patients will receive empirical 3 gm oral fosfomycin fosfomycin will be taken by mouth on an empty stomach i.e. 2-3 hours after meals preferably in the evening before bed time after emptying the bladder. The contents of 1 packet of Monuril will be dissolved in a glass of water or another non-alcoholic drink and drink immediately. Do not mix with hot water. Do not take fosfomycin in its dry form. Nature: also known as phosphomycin, phosphonomycin, is a broad-spectrum antibiotic, produced by certain Streptomyces species, although it can now be made by chemical synthesis. Trade name: Monuril Company: Zambon, Pharma Con Company, Switzerland
- Group (B): Culture specific group (CG): where all patients will receive oral antibiotic according to urine culture and sensitivity, oral antibiotics will be given in the form of five days regimen.
How the urine sample will be collected? The caregiver will give the patient a sterile cup and lid, and advice her to wash herself completely then clean the perineal area from anterior to posterior by water and in standing position as male begin to urinate then stop urinating put the sterile cup and catch the rest of urine in it. Do not touch the inside of the cup or the lid. Put the lid on the cup.
One week after completing the course of treatment all patients included in the study will be subjected to colony count evaluation, to figure out the need for:
- Urine culture in fosfomycin group in case of inadequate response to treatment and to give antibiotic according.
- The change of duration or the type of antibiotic in case of inadequate response to initial treatment in the culture group.
Outcomes
Primary:
- Resolution of asymptomatic bacteriuria as measured by colony count.
- Time frame: 1 week
Secondary:
- Side effects of fosfomycin as, nausea, diarrhea, headache, vaginal itching, runny nose, back pain Side effects from other antibiotics in culture and sensitivity group
- Need for further treatment, either extending the course of treatment into 5 or 7 days regimen or changing the antibiotic in case of inadequate initial response.
- Need for further investigations, as urine culture and sensitivity for fosfomycin group in case of inadequate response on empirical treatment.
- Conditions
- Urinary Tract Infection
- Being tested
- phosphomycin, Culture specific antibiotic therapy, Pre-treatment Urine Culture, Antimicrobial sensitivity testing, Post-treatment urine culture
- 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.
phosphomycinDrug
Single dose 3 gm oral fosfomycin will be taken by mouth on an empty stomach
Culture specific antibiotic therapyDrug
Culture-specific antibiotic treatment for 5 days
Pre-treatment Urine CultureDiagnostic test
Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
Antimicrobial sensitivity testingDiagnostic test
Susceptibility of urinary pathogens to various antimicrobials
Post-treatment urine cultureDiagnostic test
Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
| Study group | Role | What they receive |
|---|---|---|
| Fosfomycin group (FG) | Active comparator | Pre-treatment Urine culture will be done then all patients will receive empirical 3 gm oral phosphomycin fosfomycin will be taken by mouth on an empty stomach i.e. 2-3 hours after meals preferably in the evening before bed time after emptying the bladder.
The contents of 1 packet of Monuril will be dissolved in a glass of water or another non-alcoholic drink and drink immediately. Do not mix with hot water. Do not take fosfomycin in its dry form.
Response to treatment will be assessed by post-treatment urine culture. Receives: Drug: phosphomycin; Diagnostic Test: Pre-treatment Urine Culture; Diagnostic Test: Post-treatment urine culture |
| Culture specific group (CG): | Active comparator | Pre-treatment Urine culture and antimicrobial sensitivity testing will be done then all patients will receive oral culture specific antibiotic therapy in the form of five days regimen.
Response to treatment will be assessed by post-treatment urine culture. Receives: Drug: Culture specific antibiotic therapy; Diagnostic Test: Pre-treatment Urine Culture; Diagnostic Test: Antimicrobial sensitivity testing; Diagnostic Test: Post-treatment urine culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of asymptomatic bacteriuria
Decline in colony forming unit (CFU)/mL or absence of bacterial growth after treatment
Measured: 1 week
Secondary outcomes (3)
Need for further treatment
Either extending the course of treatment into 5 or 7 days regimen or changing the antibiotic in case of inadequate initial response.
Measured: 1 week
Need for further investigations
Need for urine culture and sensitivity in fosfomycin group in case of inadequate response on empirical treatment.
Measured: 1 week
Incidence of adverse drug reactions .
Incidence of adverse drug reactions as nausea, diarrhea, headache, vaginal itching, runny nose, back pain Side effects from other antibiotics in culture and sensitivity group
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed mahmoud samy, Ain Shams University
- Investigators
- Mohamed Samy, MD, Principal investigator, M Samy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548129
- Sponsor's protocol ID
- phosphomycin
- Status last verified
- May 2018
- First submitted
- 9 Jun 2016
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empirical Use of Fosfomycin as a Single Dose Oral Treatment of Asymptomatic Bacteriuria
- ClinicalTrials.gov ID
- NCT03548129
- Acronym / sponsor ID
- phosphomycin
- Conditions
- Urinary Tract Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 7 Jun 2018 (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.
Urinary tract infections (UTIs) are the most commonly occurring bacterial infections in women, Asymptomatic bacteriuria (AB) is a common complication during pregnancy, with a prevalence of 2-10%. It has been associated with a greater incidence of symptomatic urinary tract infection (UTI), as well as foetal and obstetric complications. Appropriate treatment reduces the incidence of UTI by 80-90%, as well as the risk of a premature birth and low-birth-weight baby Fosfomycin trometamol (Monuril) is approved in numerous countries worldwide, including various European countries and the USA, mainly for the treatment of uncomplicated UTIs
Detailed description
This study aims to compare between the efficacy of empirical use of fosfomycin trometamol and the use of selected antimicrobials according to urinary culture and sensitivity in curing asymptomatic bacteriuria.
All women included in the study will be counseled regarding mode of intervention and informed consent will be obtained. All cases will be subjected to complete history taking, routine antenatal examination and investigations including complete blood picture, kidney functions and urine analysis, treatment of genital infection if diagnosed. Routine obstetric ultrasound examination.
Patients will be randomized into two groups:
- Group (A): Fosfomycin group (FG); where all patients will receive empirical 3 gm oral fosfomycin fosfomycin will be taken by mouth on an empty stomach i.e. 2-3 hours after meals preferably in the evening before bed time after emptying the bladder. The contents of 1 packet of Monuril will be dissolved in a glass of water or another non-alcoholic drink and drink immediately. Do not mix with hot water. Do not take fosfomycin in its dry form. Nature: also known as phosphomycin, phosphonomycin, is a broad-spectrum antibiotic, produced by certain Streptomyces species, although it can now be made by chemical synthesis. Trade name: Monuril Company: Zambon, Pharma Con Company, Switzerland
- Group (B): Culture specific group (CG): where all patients will receive oral antibiotic according to urine culture and sensitivity, oral antibiotics will be given in the form of five days regimen.
How the urine sample will be collected? The caregiver will give the patient a sterile cup and lid, and advice her to wash herself completely then clean the perineal area from anterior to posterior by water and in standing position as male begin to urinate then stop urinating put the sterile cup and catch the rest of urine in it. Do not touch the inside of the cup or the lid. Put the lid on the cup.
One week after completing the course of treatment all patients included in the study will be subjected to colony count evaluation, to figure out the need for:
- Urine culture in fosfomycin group in case of inadequate response to treatment and to give antibiotic according.
- The change of duration or the type of antibiotic in case of inadequate response to initial treatment in the culture group.
Outcomes
Primary:
- Resolution of asymptomatic bacteriuria as measured by colony count.
- Time frame: 1 week
Secondary:
- Side effects of fosfomycin as, nausea, diarrhea, headache, vaginal itching, runny nose, back pain Side effects from other antibiotics in culture and sensitivity group
- Need for further treatment, either extending the course of treatment into 5 or 7 days regimen or changing the antibiotic in case of inadequate initial response.
- Need for further investigations, as urine culture and sensitivity for fosfomycin group in case of inadequate response on empirical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fosfomycin group (FG) | Active comparator | Drug: phosphomycin, Diagnostic Test: Pre-treatment Urine Culture, Diagnostic Test: Post-treatment urine culturePre-treatment Urine culture will be done then all patients will receive empirical 3 gm oral phosphomycin fosfomycin will be taken by mouth on an empty stomach i.e. 2-3 hours after meals preferably in the evening before bed time after emptying the bladder. The contents of 1 packet of Monuril will be dissolved in a glass of water or another non-alcoholic drink and drink immediately. Do not mix with hot water. Do not take fosfomycin in its dry form. Response to treatment will be assessed by post-treatment urine culture. |
| Culture specific group (CG): | Active comparator | Drug: Culture specific antibiotic therapy, Diagnostic Test: Pre-treatment Urine Culture, Diagnostic Test: Antimicrobial sensitivity testing, Diagnostic Test: Post-treatment urine culturePre-treatment Urine culture and antimicrobial sensitivity testing will be done then all patients will receive oral culture specific antibiotic therapy in the form of five days regimen. Response to treatment will be assessed by post-treatment urine culture. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant patients from 13 weeks to 36 weeks gestation.
- Pus cells in urine analysis >5/HPF.
- ≥ 105 colony-forming units (CFU) per millilitre of the same microorganisms in two consecutive cultures.
- No symptoms or sings suggestive of urinary tract infection.
Key exclusion criteria (11 listed)
- Presence of any urinary symptoms as burning micturition, hesitancy
- Fever and loin pain.
- Diabetes mellitus.
- Known to be allergic from any of the antimicrobial ingredients.
- Not using any antimicrobial during the course of treatment for any other infection.
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 |
|---|---|---|
| phosphomycinSingle dose 3 gm oral fosfomycin will be taken by mouth on an empty stomach | Drug | Fosfomycin group (FG) |
| Culture specific antibiotic therapyCulture-specific antibiotic treatment for 5 days | Drug | Culture specific group (CG): |
| Pre-treatment Urine CultureMid-stream urine sample will be cultured and number of CFU per mL will be determined. | Diagnostic test | Culture specific group (CG):, Fosfomycin group (FG) |
| Antimicrobial sensitivity testingSusceptibility of urinary pathogens to various antimicrobials | Diagnostic test | Culture specific group (CG): |
| Post-treatment urine cultureMid-stream urine sample will be cultured and number of CFU per mL will be determined. | Diagnostic test | Culture specific group (CG):, Fosfomycin group (FG) |
Primary outcome
Resolution of asymptomatic bacteriuria
Time frame: 1 week
Decline in colony forming unit (CFU)/mL or absence of bacterial growth after treatment
3 secondary outcomes
Need for further treatment
Time frame: 1 week
Need for further investigations
Time frame: 1 week
Incidence of adverse drug reactions .
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- 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. This study is not recruiting at the moment.
Mohamed Samy, MD principal investigator
M Samy
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing phosphomycin, Culture specific antibiotic therapy and Pre-treatment Urine Culture in people with Urinary Tract Infection, run by Ain Shams University.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Resolution of asymptomatic bacteriuria (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2018.