Infection Due to ESBL Escherichia ColiPhase 3FORESTNCT02142751
Fosfomycin Versus Meropenem or Ceftriaxone in Bacteriemic Infections Caused by Multidrug Resistance in E.Coli
A Phase 3 study testing Fosfomycin sodium intravenous, Meropenem intravenous and Ceftriaxone intravenous in people with Infection Due to ESBL Escherichia Coli, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 22 sites in Spain.
Trial summary
Enterobacterieaceae (and specially Escherichia coli) showing resistance due to multidrug-resistant Escherichia coli, plasmid mediated AmpC or quinolone resistance caused by chromosomal mechanisms have spread worldwide during the last decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Due to ESBL Escherichia Coli
- What is being tested?
- Fosfomycin sodium intravenous, Meropenem intravenous and Ceftriaxone intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 22 sitesSpain
- Study dates
- Jul 2014to Mar 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old hospitalized patients
- Negative pregnancy test in fertile women
- Episode of clinically-significant monomicrobial urinary BSI due to multidrug-resistant E.coli susceptible to fosfomycin and meropenem or ceftriaxone
- Urinary sepsis with multidrug resistant E. coli isolation from the blood cultures, requires at least one clinical criteria and one of the following urinalysis criteria:
- Clinical criteria
- UTI symptoms (dysuriac, urgency, suprapubic pain or pollakiuria)
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- Lumbar back pain
- Cost-vertebral angle tenderness
- Altered mental status in people up to 70 years old
- Intermittent or permanent indwelling foley catheter (or withdrawal during 24 hours previous) even without urinary symptoms urinalysis criteria
- Urine dipstick test positive for either nitrites or leukocyte esterase
- Positive urine culture - Signed informed consent form (ICF) executed prior to protocol screening assessments
Who cannot join
- Polymicrobial bacteremia
- No drainage of renal abscess or obstructive uropathy unresolved
- Pregnant or careening women
- Haematogenous infection
- Other concomitant infection
- Renal transplantation recipients
Show all 14Show fewer
- Polycystic kidney
- Hypersensitivity and/or intolerance to meropenem or fosfomycin or ceftriaxone
- Palliative care or life expectance < 90 days
- Septic shock at time of randomization
- New York Heart Association (NYHA) functional Class IV, hepatic cirrhosis or renal impairment receiving dialysis
- Active empiric treatment >72 hours
- Late randomization >24 hours after multidrug resistant.coli blood culture´s identification
- Participation in other clinical trial with active treatment
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites
Hospital Marina Baixa
Alicante, 03010
Hospital General Universitario de Alicante
Alicante
Hospital Parc Salud Mar
Barcelona, 08003
Hospital de la Santa Creu i San Pau
Barcelona, 08025
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Universitario de Bellvitge
Barcelona
Hospital de Cruces
Bilbao
Hospital Universitario de Burgos
Burgos, 09006
Hospital Universitario Reina Sofía
Córdoba
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Gran Canarias, 35010
Hospital Ramón y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Central de Asturias
Oviedo, 33006
Hospital Son Espases
Palma de Mallorca, 07010
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Marqués de Valdecilla
Santander, 39008
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Hospital Arnau de Vilanova
Vilanova, Lleida
Hospital Royo Villanova
Zaragoza, 50009
About this study
Official title: Phase 3, Randomized, Controlled Multicentric, Open-label Clinical Trial to Prove Non-Inferiority of Fosfomycin vs Meropenem or Ceftriaxone in the Treatment of Bacteriemic Urinary Infection Due to Multidrug Resistance in E.Coli
Enterobacterieaceae (and specially Escherichia coli) showing resistance due to multidrug-resistant Escherichia coli, plasmid mediated AmpC or quinolone resistance caused by chromosomal mechanisms have spread worldwide during the last decades. This is important because many of these isolates are also resistant to other first-line agents such as fluoroquinolones or aminoglycosides, leaving few available options for therapy, and this condition is associated with increased morbidity- mortality and length of hospital stay. While carbapenems are considered the drugs of choice for multidrug-resistant Escherichia coli and AmpC producers, recent data suggests that certain alternatives may be suitable for some types of infections.
At the present time, finding therapeutic alternatives to carbapenems and cephalosporins for the treatment of invasive infections due to multidrug-resistant Escherichia coli is critical. Fosfomycin was discovered more than 40 years ago but was not investigated according to present standards, and thus is not used in clinical practice except in desperate situations. It is one of the so-considered neglected antibiotics with high potential interest for the future.
With the aim of demonstrate the clinical non-inferiority of intravenous fosfomycin compared to meropenem or ceftriaxone in the treatment of bacteraemic urinary tract infections caused by multidrug-resistant Escherichia coli . The investigators propose a "real practise" randomised, controlled, multicentre phase III clinical trial to compare the clinical and microbiological efficacy and safety of intravenous fosfomycin (4 grammes every 6 hours) with meropenem (1 gramme every 8 hours) or ceftriaxone (1 gramme every 24 hours) as targeted therapy of the previously specified infection; change to oral therapy according to predefined options is allowed in both arms after 5 days. Follow-up for the study is planned up to 60 days.
Read the detailed description
The FOREST study is a phase 3, randomised, controlled, multicentric, open-label clinical trial to prove the noninferiority of fosfomycin versus meropenem in the targeted treatment of bacteraemic UTI due to ESBL-EC, designed as a real practice trial. It is a non-commercial, investigator-driven clinical study funded through a public competitive call by Instituto de Salud Carlos III, Spanish Ministry of Economy (PI13/01282).
The study is coordinated by investigators from Hospital Universitario Virgen Macarena in Seville, Spain; the sponsorship is performed by Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI), of which the sponsor-scientific responsibilities are delegated to the CTU (Clinical Trial Unit-Hospital Universitario Virgen del Rocío, Seville, Spain). All participating patients or their relatives must give written informed consent before any study procedures occur, including the withdrawal of biological samples for the study.
The hypothesis to test is that intravenous fosfomycin is not inferior to meropenem for the targeted treatment of bacteraemic UTI caused by ESBL-EC in terms of efficacy.
The primary objective of the study is to demonstrate that intravenous fosfomycin is not inferior to meropenem for reaching clinical and microbiological cure 5-7 days after the completion of treatment.
Secondary objectives include comparing the early clinical and microbiological response, 30-day mortality, hospital stay, recurrence rate, safety and impact on intestinal colonisation by MDR Gram-negative bacilli, evaluation of the rate of resistance development to fosfomycin and blood level concentration of fosfomycin.
- Conditions
- Infection Due to ESBL Escherichia Coli
- Being tested
- Fosfomycin sodium intravenous, Meropenem intravenous, Ceftriaxone intravenous
- Keywords
- Escherichia coli, Extended-spectrum β-lactamases (ESBLs), Bacteremia, Urinary tract infection, Bloodstream infection, Fosfomycin, Meropenem, Pharmacokinetics, intestinal colonization, Recurrence, multidrug resistance E.coli, Ceftriaxone
- Medical subject headings
- Escherichia coli Infections, Bacteremia, Urinary Tract Infections, Sepsis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosfomycin sodium intravenousDrug
Also called Generic name: Fosfomycin, Pharmaceutical form: solution for infusion, ATC code: J01J3
4g every 6 hours iv (60 min infusion)
Meropenem intravenousDrug
Also called Generic name: Meropenem, Pharmaceutical form: solution for infusion, ATC code: J01D5
1g every 8 hours (15-30 min infusion) It depends on strain sensitivity: Strain with resistance to cephalosporins
Ceftriaxone intravenousDrug
Also called generic name: ceftriaxone, Pharmaceutical form: solution for infusion, ATC code:J01DA
1g every 24 hours iv (2-4 min infusion) It depends on strain sensitivity: Strain with resistance to quinolone but sensitivity to cephalosporins
| Study group | Role | What they receive |
|---|---|---|
| Fosfomycin sodium intravenous | Experimental | 4g every 6 hours iv (60 min infusion) Receives: Drug: Fosfomycin sodium intravenous |
| Meropenem intravenous | Active comparator | 1g every 8 hours (15-30 min infusion) Receives: Drug: Meropenem intravenous |
| Ceftriaxone intravenous | Other | 1g every 24h (2-4 min) Receives: Drug: Ceftriaxone intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and microbiological cure rate
Clinical Cure: Complete resolution of infection symptoms (bacteremia and/or urinary tract infection-UTI-), present at the day on which blood culture was drawn.
Microbiological cure: Negative blood culture at day 5-7 after end of treatment. Besides this, if UTI was confirmed with a positive urine culture with the same microorganism than the blood culture, this culture should become negative.
Measured: Day 5-7 after end of treatment (test of cure)
Secondary outcomes (10)
Early clinical response
The infection was completely resolved after 5-7 days of complete treatment
Measured: After 5 -7 days of complete treatment (from the first day of study drugs administration)
Mortality
Death for any reason.
Measured: At day 30 of follow-up
Length of hospital stay
It is defined as the time from admission to hospital discharge
Measured: At day 30 of follow-up
Safety of intravenous fosfomycin in this indication
Gathering any related adverse event from the informed consent form signature to the end of follow-up.
Measured: To the last visit, at 60 plus-minus 10 days (from the first day of study drugs administration)
Recurrences (relapse and reinfection) rate
Relapse: new symptoms of UTI in patient with previously considered as clinical or microbiological cured in the visit of day 5-7 plus positive urine or blood cultures with the same microorganism isolated than the initial culture.
Re-infection: same definition but with different strain in the culture results.
Measured: To the last visit, at 60 plus-minus 10 days (from the first day of study drugs administration)
Fosfomycin steady-state plasma concentration
Therapeutic drug monitoring of fosfomycin, basic pharmacokinetic parameters will be determined.
Measured: At 3 days after treatment started
Microbiota impact of study treatment bacilli
Study treatment impact in the gut colonization of MDRGNB (Multi drug resistant Gram negative bacilli)
Measured: Screening, day 5-7, day 12
Emergence of resistant clinical isolates of Escherichia coli to fosfomycin and meropenem
Frequency of strains that develop resistance and detection of resistance mechanisms in fosfomycin treatment arm.
Measured: participants will be followed for the duration of fosfomycin, an expected average of 14 days
Early microbiological response
Cultures are negative
Measured: within the first 5 days after treatment started
Safety of intravenous antibiotic administration in this indication
Gathering any related adverse event from the informed consent form signature to the end of follow-up.
Measured: To the last visit, at 60 plus-minus 10 days (from the first day of study drugs administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infection Due to ESBL Escherichia ColiStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Network for Research in Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- JESUS RODRIGUEZ-BAÑO, MD, PhD, Study chair, Spanish Network for Research in Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142751
- Sponsor's protocol ID
- FOREST
- Acronym
- FOREST
- Status last verified
- Aug 2019
- First submitted
- 13 May 2014
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sojo-Dorado J, Lopez-Hernandez I, Rosso-Fernandez C, Morales IM, Palacios-Baena ZR, Hernandez-Torres A, Merino de Lucas E, Escola-Verge L, Bereciartua E, Garcia-Vazquez E, Pintado V, Boix-Palop L, Natera-Kindelan C, Sorli L, Borrell N, Giner-Oncina L, Amador-Prous C, Shaw E, Jover-Saenz A, Molina J, Martinez-Alvarez RM, Duenas CJ, Calvo-Montes J, Silva JT, Cardenes MA, Lecuona M, Pomar V, Valiente de Santis L, Yague-Guirao G, Lobo-Acosta MA, Merino-Bohorquez V, Pascual A, Rodriguez-Bano J; REIPI-GEIRAS-FOREST group. Effectiveness of Fosfomycin for the Treatment of Multidrug-Resistant Escherichia coli Bacteremic Urinary Tract Infections: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2137277. doi: 10.1001/jamanetworkopen.2021.37277.
PubMed 35024838Rosso-Fernandez C, Sojo-Dorado J, Barriga A, Lavin-Alconero L, Palacios Z, Lopez-Hernandez I, Merino V, Camean M, Pascual A, Rodriguez-Bano J; FOREST Study Group. Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum beta-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial. BMJ Open. 2015 Mar 31;5(3):e007363. doi: 10.1136/bmjopen-2014-007363.
PubMed 25829373
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Controlled Multicentric, Open-label Clinical Trial to Prove Non-Inferiority of Fosfomycin vs Meropenem or Ceftriaxone in the Treatment of Bacteriemic Urinary Infection Due to Multidrug Resistance in E.Coli
- ClinicalTrials.gov ID
- NCT02142751
- Acronym / sponsor ID
- FOREST / FOREST
- Conditions
- Infection Due to ESBL Escherichia Coli
- Keywords
- Escherichia coli, Extended-spectrum β-lactamases (ESBLs), Bacteremia, Urinary tract infection, Bloodstream infection, Fosfomycin, Meropenem, Pharmacokinetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Spanish Network for Research in Infectious Diseases
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 20 May 2014 (estimated)
- 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.
Enterobacterieaceae (and specially Escherichia coli) showing resistance due to multidrug-resistant Escherichia coli, plasmid mediated AmpC or quinolone resistance caused by chromosomal mechanisms have spread worldwide during the last decades. This is important because many of these isolates are also resistant to other first-line agents such as fluoroquinolones or aminoglycosides, leaving few available options for therapy, and this condition is associated with increased morbidity- mortality and length of hospital stay. While carbapenems are considered the drugs of choice for multidrug-resistant Escherichia coli and AmpC producers, recent data suggests that certain alternatives may be suitable for some types of infections.
At the present time, finding therapeutic alternatives to carbapenems and cephalosporins for the treatment of invasive infections due to multidrug-resistant Escherichia coli is critical. Fosfomycin was discovered more than 40 years ago but was not investigated according to present standards, and thus is not used in clinical practice except in desperate situations. It is one of the so-considered neglected antibiotics with high potential interest for the future.
With the aim of demonstrate the clinical non-inferiority of intravenous fosfomycin compared to meropenem or ceftriaxone in the treatment of bacteraemic urinary tract infections caused by multidrug-resistant Escherichia coli . The investigators propose a "real practise" randomised, controlled, multicentre phase III clinical trial to compare the clinical and microbiological efficacy and safety of intravenous fosfomycin (4 grammes every 6 hours) with meropenem (1 gramme every 8 hours) or ceftriaxone (1 gramme every 24 hours) as targeted therapy of the previously specified infection; change to oral therapy according to predefined options is allowed in both arms after 5 days. Follow-up for the study is planned up to 60 days.
Detailed description
The FOREST study is a phase 3, randomised, controlled, multicentric, open-label clinical trial to prove the noninferiority of fosfomycin versus meropenem in the targeted treatment of bacteraemic UTI due to ESBL-EC, designed as a real practice trial. It is a non-commercial, investigator-driven clinical study funded through a public competitive call by Instituto de Salud Carlos III, Spanish Ministry of Economy (PI13/01282).
The study is coordinated by investigators from Hospital Universitario Virgen Macarena in Seville, Spain; the sponsorship is performed by Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI), of which the sponsor-scientific responsibilities are delegated to the CTU (Clinical Trial Unit-Hospital Universitario Virgen del Rocío, Seville, Spain). All participating patients or their relatives must give written informed consent before any study procedures occur, including the withdrawal of biological samples for the study.
The hypothesis to test is that intravenous fosfomycin is not inferior to meropenem for the targeted treatment of bacteraemic UTI caused by ESBL-EC in terms of efficacy.
The primary objective of the study is to demonstrate that intravenous fosfomycin is not inferior to meropenem for reaching clinical and microbiological cure 5-7 days after the completion of treatment.
Secondary objectives include comparing the early clinical and microbiological response, 30-day mortality, hospital stay, recurrence rate, safety and impact on intestinal colonisation by MDR Gram-negative bacilli, evaluation of the rate of resistance development to fosfomycin and blood level concentration of fosfomycin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fosfomycin sodium intravenous | Experimental | Drug: Fosfomycin sodium intravenous4g every 6 hours iv (60 min infusion) |
| Meropenem intravenous | Active comparator | Drug: Meropenem intravenous1g every 8 hours (15-30 min infusion) |
| Ceftriaxone intravenous | Other | Drug: Ceftriaxone intravenous1g every 24h (2-4 min) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥18 years old hospitalized patients
- Negative pregnancy test in fertile women
- Episode of clinically-significant monomicrobial urinary BSI due to multidrug-resistant E.coli susceptible to fosfomycin and meropenem or ceftriaxone
- Urinary sepsis with multidrug resistant E. coli isolation from the blood cultures, requires at least one clinical criteria and one of the following urinalysis criteria:
- Clinical criteria
Key exclusion criteria (14 listed)
- Polymicrobial bacteremia
- No drainage of renal abscess or obstructive uropathy unresolved
- Pregnant or careening women
- Haematogenous infection
- Other concomitant 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 |
|---|---|---|
| Fosfomycin sodium intravenousAlso: Generic name: Fosfomycin, Pharmaceutical form: solution for infusion, ATC code: J01J34g every 6 hours iv (60 min infusion) | Drug | Fosfomycin sodium intravenous |
| Meropenem intravenousAlso: Generic name: Meropenem, Pharmaceutical form: solution for infusion, ATC code: J01D51g every 8 hours (15-30 min infusion) It depends on strain sensitivity: Strain with resistance to cephalosporins | Drug | Meropenem intravenous |
| Ceftriaxone intravenousAlso: generic name: ceftriaxone, Pharmaceutical form: solution for infusion, ATC code:J01DA1g every 24 hours iv (2-4 min infusion) It depends on strain sensitivity: Strain with resistance to quinolone but sensitivity to cephalosporins | Drug | Ceftriaxone intravenous |
Primary outcome
Clinical and microbiological cure rate
Time frame: Day 5-7 after end of treatment (test of cure)
Clinical Cure: Complete resolution of infection symptoms (bacteremia and/or urinary tract infection-UTI-), present at the day on which blood culture was drawn. Microbiological cure: Negative blood culture at day 5-7 after end of treatment. Besides this, if UTI was confirmed with a positive urine culture with the same microorganism than the blood culture, this culture should become negative.
10 secondary outcomes
Early clinical response
Time frame: After 5 -7 days of complete treatment (from the first day of study drugs administration)
Mortality
Time frame: At day 30 of follow-up
Length of hospital stay
Time frame: At day 30 of follow-up
Safety of intravenous fosfomycin in this indication
Time frame: To the last visit, at 60 plus-minus 10 days (from the first day of study drugs administration)
Recurrences (relapse and reinfection) rate
Time frame: To the last visit, at 60 plus-minus 10 days (from the first day of study drugs administration)
Fosfomycin steady-state plasma concentration
Time frame: At 3 days after treatment started
Microbiota impact of study treatment bacilli
Time frame: Screening, day 5-7, day 12
Emergence of resistant clinical isolates of Escherichia coli to fosfomycin and meropenem
Time frame: participants will be followed for the duration of fosfomycin, an expected average of 14 days
Early microbiological response
Time frame: within the first 5 days after treatment started
Safety of intravenous antibiotic administration in this indication
Time frame: To the last visit, at 60 plus-minus 10 days (from the first day of study drugs administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 35024838Sojo-Dorado J, Lopez-Hernandez I, Rosso-Fernandez C, Morales IM, Palacios-Baena ZR, Hernandez-Torres A, Merino de Lucas E, Escola-Verge L, Bereciartua E, Garcia-Vazquez E, Pintado V, Boix-Palop L, Natera-Kindelan C, Sorli L, Borrell N, Giner-Oncina L, Amador-Prous C, Shaw E, Jover-Saenz A, Molina J, Martinez-Alvarez RM, Duenas CJ, Calvo-Montes J, Silva JT, Cardenes MA, Lecuona M, Pomar V, Valiente de Santis L, Yague-Guirao G, Lobo-Acosta MA, Merino-Bohorquez V, Pascual A, Rodriguez-Bano J; REIPI-GEIRAS-FOREST group. Effectiveness of Fosfomycin for the Treatment of Multidrug-Resistant Escherichia coli Bacteremic Urinary Tract Infections: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2137277. doi: 10.1001/jamanetworkopen.2021.37277.
- Derived from this study: PubMed 25829373Rosso-Fernandez C, Sojo-Dorado J, Barriga A, Lavin-Alconero L, Palacios Z, Lopez-Hernandez I, Merino V, Camean M, Pascual A, Rodriguez-Bano J; FOREST Study Group. Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum beta-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial. BMJ Open. 2015 Mar 31;5(3):e007363. doi: 10.1136/bmjopen-2014-007363.
- Spanish Network Research in Infectious Diseases (Red Española de Investigación en Patología Infecciosa \[REIPI\])Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
JESUS RODRIGUEZ-BAÑO, MD, PhD study chair
Spanish Network for Research in Infectious Diseases
22 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 Fosfomycin sodium intravenous, Meropenem intravenous and Ceftriaxone intravenous in people with Infection Due to ESBL Escherichia Coli, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 22 sites in Spain.
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 12 inclusion and 14 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical and microbiological cure rate (time frame: Day 5-7 after end of treatment (test of cure)). 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 NCT02142751, 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 6 Aug 2019.