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The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NXL103 | Experimental | BID for 7-14 days orally |
|
| Linezolid | Active Comparator | BID for 7-14 days orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXL103 | Drug | BID for 7-14 days |
| |
| Linezolid |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response at the early follow-up visit (Test of cure) | 7 days post therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome at the late follow-up visit | 21 days post therapy | |
| Clinical outcome at the end of treatment | 10-14 days therapy | |
| Microbiological outcome at the early follow-up visit (Test of cure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kuligowski, MD | Novexel Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Chula Vista Research Office | Chula Vista | California | 91911 | United States | ||
| Fountain Valley Regional Hospital and Medical Center |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 17, 2011 | |
| Unrelease | Yes | |
| Release | Jul 6, 2011 |
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| Drug |
BID for 7-14 days |
|
| 7 days post-therapy |
| Safety Profiles (safety and tolerability) | throughout the study |
| Population pharmacokinetic profile of the experimental study drug | Day 1-5 while on study drug |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Sharp Grossmont Research Office | La Mesa | California | 91942 | United States |
| Tri-City Oceanside Office | Oceanside | California | 92056 | United States |
| Southeast Regional Research Group | Columbus | Georgia | 31904 | United States |
| Southeast Regional Research Group | Savannah | Georgia | 31406 | United States |
| Idaho Falls Infectious Diseases | Idaho Falls | Idaho | 83404 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Infectious Diseaes MPLS-LTD | Minneapolis | Minnesota | 55422 | United States |
| Mercury Street Medical Group | Butte | Montana | 59701 | United States |
| RPS Infectious Diseases | West Reading | Pennsylvania | 19611 | United States |
| Roosevelt Hospital | Guatemala City | 1011 | Guatemala |
| UNICAR | Guatemala City | 1011 | Guatemala |
| Military Health Center | Guatemala City | Guatemala |
| Private Hospital | Quetzaltenango | Guatemala |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 17, 2011 | Yes | |||
| Jul 6, 2011 | Yes |
| ID | Term |
|---|---|
| C509060 | flopristin, linopristin drug combination |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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