Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)
NCT ID: NCT03710694
Last Updated: 2019-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
260 participants
INTERVENTIONAL
2018-10-31
2019-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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DAV132 group
Patients randomized to the DAV132 arm will be administered DAV132 concomitantly with fluoroquinolones.
DAV132
DAV132:
* Dosage: 15 g/day activated charcoal (22.5 g/day DAV132)
* Route: Oral
* Duration: duration of fluoroquinolone treatment + 2 days
DAV132 is regulated as a medical device in Europe and as a drug in the United States of America.
No DAV132 group
Patients randomized to the No DAV132 arm will receive only fluoroquinolones, according to local standard of care.
No interventions assigned to this group
Interventions
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DAV132
DAV132:
* Dosage: 15 g/day activated charcoal (22.5 g/day DAV132)
* Route: Oral
* Duration: duration of fluoroquinolone treatment + 2 days
DAV132 is regulated as a medical device in Europe and as a drug in the United States of America.
Eligibility Criteria
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Inclusion Criteria
2. Hospitalized patients requiring a systemic antibiotic treatment for a proven or strongly suspected bacterial infection (lower respiratory tract infection \[LRTI\], complicated urinary tract infection \[cUTI\]) or prophylactic treatment of febrile neutropenia for neutropenic patient
3. Patients who are intended to receive one of the following FQs: moxifloxacin, levofloxacin, or ciprofloxacin, by oral or parenteral route, for an intended duration of 5 days (minimum) to 21 days (maximum), in monotherapy
4. Patients expected to stay in hospital for at least 3 days after randomization
5. Patients with the following conditions:
\- Previous history of CDI (no more than 2 episodes) within six months prior to study inclusion
OR
\- Patient aged ≥65 years, and presenting with at least two of the following:
* Previous cumulated exposure of at least 5 days to any antibiotics within the last 90 days
* Patients who have at least one concurrent severe comorbidity among the following: malignant disease, chronic renal failure, cardiopulmonary condition (such as chronic congestive heart failure or severe arterial hypertension), diabetes mellitus, or liver cirrhosis
* Previous hospitalization of more than 72h within the last 90 days, or patient receiving long-term nursing care for more than one month within the last 90 days
6. Female patients participating in the study must be:
\- of non-childbearing potential: surgically sterilized at least 3 months prior to inclusion, or postmenopausal (menopause is defined as being aged \>60 years, or aged between 45 and 60 years and being amenorrheic for ≥2 years)
OR
\- of childbearing potential, and:
• using an efficient double contraception from inclusion up to 24 hours after the end of the treatment period: hormonal contraception (including patch, contraceptive ring, etc.), intra-uterine device, or other mechanical contraception method
AND
condom, or diaphragm or cervical/vault cap, or spermicide
AND
must have a negative urine pregnancy test prior to inclusion to the study.
7. Patients who have given their written informed consent prior to undertaking any study-related procedure.
Exclusion Criteria
2. Fluoroquinolone indication other than LRTI, cUTI, or febrile neutropenia prophylaxis
3. Patients with suspected or diagnosed CDI at screening, and/or receiving a treatment effective against CDI
4. Patients with diarrhea corresponding to Bristol stool chart types 5-7, combined with a stool frequency of at least three stools in 24 or fewer consecutive hours, regardless of its etiology
5. Patients using probiotics for prevention of CDI and refusing to stop them at inclusion and during the study
6. Patients currently taking activated charcoal
7. Patients who have received a fecal microbial transplantation within the last 90 days prior to study screening
8. A critically ill patient for whom transfer to an intensive care unit is scheduled, or patient who may likely have critical clinical deterioration within 48 hours;
9. Patients with serious, uncontrolled disease, including but not limited to neutropenia expected to last \>7 days (Investigator discretion) or with an estimated life expectancy shorter than 6 months
10. Patients diagnosed with any cancer requiring taxane-based chemotherapy
11. Patients with digestive stoma, known conditions at risk for intestinal obstruction, or known achlorhydria
12. Contra-indication to oral therapy (eg, severe nausea/vomiting or ileus) or patient having tube feeding
13. Patients unable or expected to be unable within 48 hours to receive a medication by oral route administration
14. Known hypersensitivity to the activated charcoal, or to any of the constituents or excipients of DAV132
15. Patients taking any drug/medication acting on (eg, metronidazole; sulfasalazine) or absorbed in the colon.
16. Female patients planning a pregnancy, pregnant or breastfeeding
17. Patients already included into this study
18. Patients in an exclusion period of a previous study
19. Patients with any social or logistical condition which in the opinion of the Investigator, may interfere with the conduct of the study, such as incapacity to understand well, not willing to collaborate, or cannot easily be contacted after discharge
20. Patients not covered by a health insurance system where applicable and in compliance with the recommendations of the national laws in force relating to biomedical research.
21. Patients under administrative or legal supervision.
18 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Da Volterra
INDUSTRY
Responsible Party
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Principal Investigators
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Maria J.G.T Vehreschild, MD
Role: PRINCIPAL_INVESTIGATOR
Universitaetsklinikum Frankfurt
Locations
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Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Kozloduy EOOD Internal Department
Kozloduy, , Bulgaria
MHAT "Dr Nikola Vasilev " AD 1
Kyustendil, , Bulgaria
MHAT "Dr. Stamen Iliev" AD 4
Montana, , Bulgaria
Pernik EOOD Specialized Hospital for Active Treatment of Pulmonary Diseases - Phthisiatry Department
Pernik, , Bulgaria
Hosp Ruse EOOD
Rousse, , Bulgaria
Multiprofile Hospital for Active Treatment Silistra AD Department of pneumology and phtisiatry
Silistra, , Bulgaria
Military Medical Academy, Clinic of Infectious Diseases
Sofia, , Bulgaria
UMHATEM N.I.Pirogov Department of internal diseases Clinic of internal diseases
Sofia, , Bulgaria
MHAT Sv. Anna Clinic of Urology
Varna, , Bulgaria
Universitätskliniken Köln (AöR) Klinik I für Innere Medizin
Cologne, , Germany
Universitaetsklinikum Frankfurt, Medizinische Klinik II
Frankfurt am Main, , Germany
Universitaetsklinikum Jena Klinik für Innere Medizin IV
Jena, , Germany
Medizinische Universitaetsklinik Abteilung Innere Medizin I
Tübingen, , Germany
Institutului Clinic Fundeni, Secţia Clinica Urologie III
Bucharest, , Romania
Spitalul Clinic de Boli Infecţioase şi Tropicale Dr. Victor Babeş, Secţia Pneumologie II
Bucharest, , Romania
Spitalului de Boli Infectioase si Tropicale "Dr. Victor Babes" Sectia Clinica de Boli Infectioase si Tropicale VI - adult
Bucharest, , Romania
Institutul de Pneumoftiziologie "MariusNasta" (Pavilionul IV), Sectia Pneumologie VII
Bucharest, , Romania
The Oncology Institute "Prof. Dr. Ion Chiricuţă"
Cluj-Napoca, , Romania
Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca, Secţia Clinică Pneumologie I
Cluj-Napoca, , Romania
Spitalul Clinic de Boli Infecţioase si Pneumoftiziologie Victor Babeş Craiova, Secţia Boli Infecţioase Adulţi II
Craiova, , Romania
Spitalului Universitar de Urgenta Elias, Clinica Universitara de Geriatrie, Gerontologie si Psihogeriatrie, Sos. Bucuresti-Ploiesti
Otopeni, , Romania
Spitalul Clinic de Boli Infecţioase si Pneumoftiziologie "Dr. Victor Babeş" Timişoara, Clinica II Pneumologie
Timișoara, , Romania
Spitalului Clinic de Boli Infecţioase şi Pneumoftiziologie "Dr. Victor Babeş", Secţia Pneumologie II
Timișoara, , Romania
Spitalului Clinic Judeţean de Urgenţă "Pius Brînzeu" Timişoara, Secţia Clinică Urologie
Timișoara, , Romania
Clinical Hospital Centre Bezanijska Kosa Pulmonology Department
Belgrade, , Serbia
General Hospital Department for Lung Diseases and Tuberculosis
Čačak, , Serbia
Clinical Centre Kragujevac Clinic for Infectious Diseases
Kragujevac, , Serbia
Clinical Centre of Nis Clinic for Lung Diseases
Niš, , Serbia
Health Centre Uzice Department for Lung Diseases and Tuberculosis
Užice, , Serbia
Countries
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References
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de Gunzburg J, Ducher A, Modess C, Wegner D, Oswald S, Dressman J, Augustin V, Feger C, Andremont A, Weitschies W, Siegmund W. Targeted adsorption of molecules in the colon with the novel adsorbent-based medicinal product, DAV132: A proof of concept study in healthy subjects. J Clin Pharmacol. 2015 Jan;55(1):10-6. doi: 10.1002/jcph.359. Epub 2014 Jul 16.
de Gunzburg J, Ghozlane A, Ducher A, Le Chatelier E, Duval X, Ruppe E, Armand-Lefevre L, Sablier-Gallis F, Burdet C, Alavoine L, Chachaty E, Augustin V, Varastet M, Levenez F, Kennedy S, Pons N, Mentre F, Andremont A. Protection of the Human Gut Microbiome From Antibiotics. J Infect Dis. 2018 Jan 30;217(4):628-636. doi: 10.1093/infdis/jix604.
Burdet C, Sayah-Jeanne S, Nguyen TT, Hugon P, Sablier-Gallis F, Saint-Lu N, Corbel T, Ferreira S, Pulse M, Weiss W, Andremont A, Mentre F, de Gunzburg J. Antibiotic-Induced Dysbiosis Predicts Mortality in an Animal Model of Clostridium difficile Infection. Antimicrob Agents Chemother. 2018 Sep 24;62(10):e00925-18. doi: 10.1128/AAC.00925-18. Print 2018 Oct.
Burdet C, Sayah-Jeanne S, Nguyen TT, Miossec C, Saint-Lu N, Pulse M, Weiss W, Andremont A, Mentre F, de Gunzburg J. Protection of Hamsters from Mortality by Reducing Fecal Moxifloxacin Concentration with DAV131A in a Model of Moxifloxacin-Induced Clostridium difficile Colitis. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00543-17. doi: 10.1128/AAC.00543-17. Print 2017 Oct.
Other Identifiers
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CIV-18-03-023465
Identifier Type: OTHER
Identifier Source: secondary_id
DAV132-CL-2001
Identifier Type: -
Identifier Source: org_study_id