Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

Bacterial Infections Clinical Trial

Official title:

A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378480
• Other study ID #: PTK0796-ABSI-1108
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: March 2019
• Source: Paratek Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 655
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients, ages 18 years or older who have signed the informed consent

• Has a qualifying skin and skin structure infection

• Female patients must not be pregnant at the time of enrollment

• Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

• Infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days

• Evidence of significant immunological disease

• Severe sepsis or septic shock

• Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid

• Has received an investigational drug within past 30 days

• Women who are pregnant or nursing

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Skin Structures and Soft Tissue Infections
• Soft Tissue Infections

Intervention

Drug:
• Omadacycline
Injection for IV dosing; Tablets for oral dosing
• Linezolid
Infusion solution for IV dosing; Tablets for oral dosing

Locations

Country	Name	City	State
Bulgaria	Site 104	Pleven
Bulgaria	Site 102	Plovdiv
Bulgaria	Site 105	Plovdiv
Bulgaria	Site 103	Rousse
Bulgaria	Site 101	Sofia
Croatia	Site 205	Slavonski Brod
Croatia	Site 201	Zagreb
Croatia	Site 202	Zagreb
Croatia	Site 203	Zagreb
Croatia	Site 204	Zagreb
Greece	Site 207	Athens
Greece	Site 211	Athens
Greece	Site 208	Thessaloniki
Greece	Site 209	Thessaloniki
Hungary	Site 110	Budapest
Hungary	Site 111	Budapest
Hungary	Site 114	Miskolc
Hungary	Site 113	Szeged
Israel	Site 213	Holon
Israel	Site 219	Kfar-Saba
Israel	Site 214	Nazareth
Israel	Site 216	Safed
Latvia	Site 122	Daugavpils
Latvia	Site 123	Liepaja
Latvia	Site 124	Rezekne
Latvia	Site 120	Riga
Latvia	Site 121	Riga
Peru	Site 234	Cusco
Peru	Site 233	Lima
Peru	Site 236	Lima
Peru	Site 238	Lima
Peru	Site 239	Lima
Peru	Site 237	Trujillo
Poland	Site 130	Bydgoszcz
Poland	Site 133	Katowice
Poland	Site 131	Lodz
Poland	Site 134	Olsztyn
Poland	Site 132	Warszawa
Romania	Site 141	Bucharest
Romania	Site 142	Bucharest
Romania	Site 146	Bucharest
Romania	Site 144	Cluj-Napoca
Romania	Site 140	Craiova
Romania	Site 143	Târgu-Mures
Romania	Site 145	Timisoara
South Africa	Site 241	Benoni	Gauteng
South Africa	Site 244	Thabazimbi	Limpopo
Spain	Site 221	Barcelona	Cataluna
Spain	Site 222	Terrassa	Barcelona
Turkey	Site 247	Ankara
Turkey	Site 246	Trabzon
Ukraine	Site 172	Dnipropetrovsk
Ukraine	Site 173	Dnipropetrovsk
Ukraine	Site 179	Kharkiv
Ukraine	Site 171	Kyiv
Ukraine	Site 170	Lviv
Ukraine	Site 174	Odesa
Ukraine	Site 175	Uzhhorod
Ukraine	Site 178	Vinnytsia
Ukraine	Site 176	Zaporizhia
United States	Site 256	Augusta	Georgia
United States	Site 273	Buffalo	New York
United States	Site 266	Butte	Montana
United States	Site 262	Chula Vista	California
United States	Site 253	Columbus	Georgia
United States	Site 268	Detroit	Michigan
United States	Site 254	La Mesa	California
United States	Site 263	Las Vegas	Nevada
United States	Site 259	Miami	Florida
United States	Site 261	Mobile	Alabama
United States	Site 258	Oceanside	California
United States	Site 255	Rapid City	South Dakota
United States	Site 252	Santa Ana	California
United States	Site 260	Santa Ana	California
United States	Site 270	Somers Point	New Jersey
United States	Site 257	Springfield	Massachusetts
United States	Site 269	Stockton	California
United States	Site 264	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Paratek Pharmaceuticals Inc

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Greece,  Hungary,  Israel,  Latvia,  Peru,  Poland,  Romania,  South Africa,  Spain,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Early Clinical Response	Early clinical response is defined as clinical success, which is categorized as survival with at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to Screening measurements, without receiving any rescue antibacterial therapy. An indeterminate classification is used for a response that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason.	Screening; 48 to 72 hours after the first dose of test article
Secondary	Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit	At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the infection was sufficiently resolved such that further antibacterial therapy was not needed. These participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the End-of-Treatment (EOT) Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation. Indeterminate: clinical response to test article could not be adequately inferred.	Screening; 7 to 14 days after the last day of therapy
Secondary	Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population	At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the infection was sufficiently resolved such that further antibacterial therapy was not needed. These participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the EOT Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation.	Screening; 7 to 14 days after the last day of therapy
Secondary	Number of Participants With the Indicated Type of Adverse Event (AE)	An AE is defined as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a test article or in a clinical study. The event does not need to be causally related to the test article or clinical study. A serious adverse event (SAE) is defined as an event that resulted in death, was life-threatening, required hospitalization or prolongation of an existing hospitalization, resulted in a persistent or significant disability or incapacity, resulted in cancer, or resulted in a congenital anomaly or birth defect. A treatment-emergent AE (TEAE) is defined as any AE that newly appeared, increased in frequency, or worsened in severity on or after the initiation of active test article. Vital sign measurements, electrocardiogram findings, and laboratory values classified as adverse events were included in the analysis. Data are presented as the number of participants with at least 1 of the event.	0 to 37 days