Study of Debio 1450 for Bacterial Skin Infections



Status:Completed
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/4/2019
Start Date:May 2015
End Date:September 2016

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A Phase 2, Randomized, Double-Blind, Multicenter Study of Safety, Tolerability, and Efficacy of Debio 1450 vs Vancomycin (IV)/Linezolid (Oral) in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococcus Sensitive or Resistant to Methicillin

The primary objective of this study is to evaluate the efficacy of 2 different doses of
intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in
the treatment of patients with staphylococcal ABSSSI.


Inclusion Criteria:

- Has clinically documented infection of the skin or skin structure suspected or
documented to be caused by a staphylococcal pathogen

- Meets other protocol-specified criteria for qualification and contraception

- Is willing and able to remain confined in the study unit for the entire duration of
each treatment period and comply with restrictions related to food, drink and
medications

- Voluntarily consents to participate and provides written informed consent prior to any
protocol-specific procedures

Exclusion Criteria:

- Has history or current use of over-the-counter medications, dietary supplements, or
drugs (including nicotine and alcohol) outside protocol-specified parameters

- Has signs, symptoms or history of any condition that, per protocol or in the opinion
of the investigator, might compromise:

1. the safety or well-being of the participant or study staff;

2. the safety or well-being of the participant's offspring (such as through
pregnancy or breast-feeding);

3. the analysis of results
We found this trial at
22
sites
760 North Euclid Street
Anaheim, California 92801
Principal Investigator: Quang Dinh Vo
Phone: 714-780-0076
16
mi
from 91732
Anaheim, CA
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Anaheim, California 92804
Principal Investigator: Richard Keech
Phone: 714-761-2888
17
mi
from 91732
Anaheim, CA
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Buena Park, California 90620
Principal Investigator: James Chen
Phone: 714-827-1899
16
mi
from 91732
Buena Park, CA
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Butte, Montana 59701
Principal Investigator: John Pullman
Phone: 406-723-1375
873
mi
from 91732
Butte, MT
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Chula Vista, California 91911
Principal Investigator: J. Scott Overcash
Phone: 619-955-5246
116
mi
from 91732
Chula Vista, CA
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Columbus, Georgia 31904
Principal Investigator: Jeffrey Kingsley, Dr.
Phone: 706-571-1087
1902
mi
from 91732
Columbus, GA
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Gainesville, Florida 32610
Principal Investigator: David Mozingo
Phone: 352-265-0111
2103
mi
from 91732
Gainesville, FL
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Houston, Texas 77070
Principal Investigator: Munib Daudjee
Phone: 713-777-5343
1342
mi
from 91732
Houston, TX
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La Mesa, California 91942
Principal Investigator: Sinikka Green
Phone: 619-567-1550
106
mi
from 91732
La Mesa, CA
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Las Vegas, Nevada 89109
Principal Investigator: Heidi Kabler
Phone: 702-410-2970
214
mi
from 91732
Las Vegas, NV
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Long Beach, California 90806
Principal Investigator: Barry Heller
Phone: 562-458-6142
21
mi
from 91732
Long Beach, CA
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Long Beach, California 90804
Principal Investigator: Robert Eyzaguirre
Phone: 562-366-2554
23
mi
from 91732
Long Beach, CA
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Modesto, California 95350
Principal Investigator: Brett Farley
Phone: 209-549-9538
299
mi
from 91732
Modesto, CA
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Oceanside, California 92056
Principal Investigator: Paul J. Manos
Phone: 760-631-3056
73
mi
from 91732
Oceanside, CA
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Orlando, Florida 32811
Principal Investigator: Syed Naseeruddin
Phone: 407-573-2352
2181
mi
from 91732
Orlando, FL
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Royal Oak, Michigan 48073
Principal Investigator: Matthew Sims
Phone: 248-551-4603
1962
mi
from 91732
Royal Oak, MI
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Somers Point, New Jersey 08244
Principal Investigator: Christopher Lucasti
Phone: 609-927-6662
2409
mi
from 91732
Somers Point, NJ
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Splendora, Texas 77372
Principal Investigator: Najmuddin Karimjee
Phone: 713-528-8818
1359
mi
from 91732
Splendora, TX
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Sylmar, California 91342
Principal Investigator: David Talan
Phone: 818-364-3115
28
mi
from 91732
Sylmar, CA
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Teaneck, New Jersey 07666
Principal Investigator: Thomas Birch
Phone: 201-541-6384
2431
mi
from 91732
Teaneck, NJ
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Toledo, Ohio 43608
Principal Investigator: Luis Jauregui-Peredo
Phone: 419-251-8466
1938
mi
from 91732
Toledo, OH
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West Palm Beach, Florida 33401
Principal Investigator: Olayemi Osiyemi
Phone: 561-855-7871
2304
mi
from 91732
West Palm Beach, FL
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