AzTrials
AzTrials

Bacterial InfectionsPhase 3NCT00366249

Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.

A Phase 3 study testing Tigecycline and Ertapenem in people with Bacterial Infections and Diabetic Foot, run by Wyeth is now a wholly owned subsidiary of Pfizer at 211 sites in 39 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bacterial Infections, Diabetic Foot, Osteomyelitis
What is being tested?
Tigecycline and Ertapenem
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,061 participants
Where
211 sitesin 39 countries
Study dates
Jan 2007to Mar 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Main inclusion criteria:

  • Men and women aged 18 or older with diabetes and a qualifying foot infection. People with evidence of a diabetic foot infection with osteomyelitis may qualify for the osteomyelitis substudy arm.

Main exclusion criteria:

  • People with additional significant disease, infection with resistant pathogens, contraindication, or hypersensitivity to any test article or related antibiotic.

Trial locations and contacts

211 sites in 39 countries.

211 sites in 39 countries

Argentina27 sites

  • Study site

    Buenos Aires, Buenos Aires, CP 1428

  • Study site

    Buenos Aires, 1180

  • Study site

    Buenos Aires, 1181

  • Study site

    Buenos Aires, 1428

  • Study site

    Buenos Aires, CP C1180 AAX

  • Study site

    Chivilcoy, Buenos Aires, 6620

  • Study site

    Ciudadela, 3 de Febrero, Buenos Aires, 1702

  • Study site

    Ciudadela, 3 de Febrero, Buenos Aires, CP 1702

  • Study site

    Córdoba, 5000

  • Study site

    Córdoba, 5004

  • Study site

    Córdoba, 5016

  • Study site

    Córdoba, CP 5000

  • Study site

    Córdoba, CP 5016

  • Study site

    La Plata, Buenos Aires, 1072

  • Study site

    La Plata, Buenos Aires, 1900

  • Study site

    La Plata, Buenos Aires, CP 1900

  • Study site

    Loma Hermosa, Buenos Aires, 1657

  • Study site

    Loma Hermosa, Buenos Aires, CP 1657

  • Study site

    Mar del Plata, Buenos Aires, 7602

  • Study site

    Mendoza, 5500

  • Study site

    Merlo, Buenos Aires, 1722

  • Study site

    Morón, Buenos Aires, 1072

  • Study site

    Paraná, Entre Ríos Province, 3100

  • Study site

    Paraná, Entre Ríos Province, CP 3100

  • Study site

    Rosario, Santa Fe Province, 2000

  • Study site

    San Miguel de Tucumán, Tucumán Province, 4000

  • Study site

    Tunuyan, Mendoza Province, 5560

Other trials in Argentina

United States26 sites

  • Study site

    Baltimore, Maryland, 21224

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Columbia, South Carolina, 29203

  • Study site

    Dallas, Texas, 75203

  • Study site

    Evanston, Illinois, 60201

  • Study site

    Honolulu, Hawaii, 96814

  • Study site

    Lima, Ohio, 45801

  • Study site

    Los Angeles, California, 90010

  • Study site

    Los Angeles, California, 91342

  • Study site

    North Chicago, Illinois, 60064

  • Study site

    Northridge, California, 91326

  • Study site

    Orlando, Florida, 32801

  • Study site

    Orlando, Florida, 32806

  • Study site

    Pensacola, Florida, 32501

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Francisco, California, 94115

  • Study site

    Somers Point, New Jersey, 08244

  • Study site

    Springfield, Illinois, 62701

  • Study site

    Springfield, Illinois, 62791

  • Study site

    Sylmar, California, 91342

  • Study site

    Toledo, Ohio, 43614

  • Study site

    Torrance, California, 90502

  • Study site

    West Palm Beach, Florida, 33407

  • Study site

    West Reading, Pennsylvania, 19610

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Russia17 sites

  • Study site

    Chelyabinsk, 454 021

  • Study site

    Kemerovo, 650061

  • Study site

    Moscow, 111020

  • Study site

    Moscow, 113152

  • Study site

    Moscow, 127299

  • Study site

    Moscow, 127486

  • Study site

    Moscow, 129110

  • Study site

    Moscow, 129327

  • Study site

    Nizhny Novgorod, 603005

  • Study site

    Nizhny Novgorod, 603076

  • Study site

    Novosibirsk, 630117

  • Study site

    Omsk, 644021

  • Study site

    Saint Petersburg, 196247

  • Study site

    Saint Petersburg, 198095

  • Study site

    Smolensk, 214019

  • Study site

    Yaroslavl

  • Study site

    Yekaterinburg, 620109

Other trials in Russia

Mexico9 sites

  • Study site

    Colonia El Ritiro, Guadalajara, 44280

  • Study site

    Durango, 34000

  • Study site

    Guadalajara, Jalisco, 44260

  • Study site

    Hermosillo, Sonora, 83190

  • Study site

    Mendoza, Mendoza, CP 5500

  • Study site

    San Luis Potosí City, 78210

  • Study site

    San Luis Potosí City, CP 78210

  • Study site

    Santa Fe, Santa Fe, CP 2000

  • Study site

    Veracruz, 91910

Other trials in Mexico

Canada8 sites

  • Study site

    Chicoutimi, Quebec, G7H 5H6

  • Study site

    Hamilton, Ontario, L8V 1C3

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Sherbrooke, Quebec, J1H 5N4

  • Study site

    Trois-Rivières, Quebec, G8Z 3R9

  • Study site

    Vancouver, British Columbia, V6Z 1Y6

  • Study site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Lithuania8 sites

  • Study site

    Kaunas, 47144

  • Study site

    Kaunas, 50009

  • Study site

    Kaunas, LT-50009

  • Study site

    Klaipėda, 92288

  • Study site

    Panevezys, 35144

  • Study site

    Šiauliai, 76231

  • Study site

    Vilnius, 10207

  • Study site

    Vilnius, LT-10207

Other trials in Lithuania

Ukraine8 sites

  • Study site

    Cherkassy, 18009

  • Study site

    Dnipro, 49001

  • Study site

    Kiev, 2125

  • Study site

    Kyiv, 02175

  • Study site

    Kyiv, 2175

  • Study site

    Lviv, 79010

  • Study site

    Vinnytsia, 21010

  • Study site

    Zaporizhzhya, 69600

Other trials in Ukraine

Hungary7 sites

  • Study site

    Budapest, 1076

  • Study site

    Budapest, 1082

  • Study site

    Budapest, H-1027

  • Study site

    Debrecen, 4012

  • Study site

    Győr, 9024

  • Study site

    Kistarcsa, 2143

  • Study site

    Székesfehérvár, 8000

Other trials in Hungary

Slovakia7 sites

  • Study site

    Banská Bystrica, 975 17

  • Study site

    Banska.Bysterica, 97517

  • Study site

    Bratislava, 813 69

  • Study site

    Ľubochňa, 034 91

  • Study site

    Martin, 036 59

  • Study site

    Nitra, 949 01

  • Study site

    Nové Zámky, 9401

Other trials in Slovakia

Latvia6 sites

  • Study site

    Liepāja, 3401

  • Study site

    Riga, 1001

  • Study site

    Riga, 1002

  • Study site

    Riga, 1038

  • Study site

    Riga, LV-1001

  • Study site

    Riga, LV-1038

Other trials in Latvia

Poland6 sites

  • Study site

    Bielsko-Biala, 43-300

  • Study site

    Cieszyn, 43-400

  • Study site

    Gdansk, 80-211

  • Study site

    Lodz, 91-425

  • Study site

    Warsaw, 02-097

  • Study site

    Wroclaw, 50-326

Other trials in Poland

Belgium5 sites

  • Study site

    Bornem, 2880

  • Study site

    Brussels, 1070

  • Study site

    Brussels, 1080

  • Study site

    Brussels, 1090

  • Study site

    Pellenberg, 3212

Other trials in Belgium

China5 sites

  • Study site

    Beijing, 100101

  • Study site

    Beijing, 100730

  • Study site

    Guangzhou, 510120

  • Study site

    Harbin, Heilongjiang, 150086

  • Study site

    Tianjin, 300070

Other trials in China

Germany5 sites

  • Study site

    Bochum, North Rhine-Westphalia, 44789

  • Study site

    Gelsenkirchen, North Rhine-Westphalia, 45891

  • Study site

    Giessen, Hesse, 35392

  • Study site

    Münster, Northrhien-Westphalia, 48129

  • Study site

    Rheine, North Rhine-Westphalia, 48431

Other trials in Germany

Spain5 sites

  • Study site

    Barcelona, 8907

  • Study site

    Getafe Madrid, 28905

  • Study site

    Granada, 18012

  • Study site

    Madrid, 28007

  • Study site

    Palma de Mallorca, 7198

Other trials in Spain

United Kingdom5 sites

  • Study site

    Birmingham, West Midlands, B29 6JD

  • Study site

    Birmingham, B95SS

  • Study site

    London, SE5 9RS

  • Study site

    Oxford, OX3 7LD

  • Study site

    Wishaw, Lanarkshire, ML2 0DP

Other trials in United Kingdom

Estonia4 sites

  • Study site

    Kohtla-Järve, Ida-Virumaa, 30322

  • Study site

    Tallinn, 13419

  • Study site

    Tartu, 50410

  • Study site

    Tartu, 51014

Other trials in Estonia

India4 sites

  • Study site

    Bangalore, Karnataka, 560002

  • Study site

    Jaipur, Rajasthan, 302001

  • Study site

    Pune, Maharashtra, 411001

  • Study site

    Vadodara, Gujarat, 390001

Other trials in India

Romania4 sites

  • Study site

    Bacau, 600114

  • Study site

    Bucharest, 20475

  • Study site

    Cluj-Napoca, 400006

  • Study site

    Lasi, 700111

Other trials in Romania

South Korea4 sites

  • Study site

    Gyeonggi-do, 425-801

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 136-075

  • Study site

    Seoul, 138-736

Other trials in South Korea

Croatia3 sites

  • Study site

    Zadar, 23 000

  • Study site

    Zagreb, 10 000

  • Study site

    Zagreb, 10000

Other trials in Croatia

Greece3 sites

  • Study site

    Athens, 106 76

  • Study site

    Holargos, Athens, 11527

  • Study site

    Rio-Patras, 265 04

Other trials in Greece

Italy3 sites

  • Study site

    Abano Terme (PD), 35031

  • Study site

    Pisa, 56124

  • Study site

    Rome, 133

Other trials in Italy

South Africa3 sites

  • Study site

    Benoni, Gauteng, 1501

  • Study site

    Port Elizabeth, Eastern Cape, 6014

  • Study site

    Pretoria, Gauteng, 84

Other trials in South Africa

Sweden3 sites

  • Study site

    Copenhagen, 2400

  • Study site

    Huddinge, 141 86

  • Study site

    Uppsala, 751 85

Other trials in Sweden

Turkey (Türkiye)3 sites

  • Study site

    Adana, 1330

  • Study site

    Capa-Istanbul, 34390

  • Study site

    Istanbul, 34303

Other trials in Turkey (Türkiye)

Australia2 sites

  • Study site

    Melbourne, Victoria, 3050

  • Study site

    Melbourne, Victoria, 3128

Other trials in Australia

Brazil2 sites

  • Study site

    Rio de Janeiro, 20211-340

  • Study site

    São Paulo, 05422-970

Other trials in Brazil

Chile2 sites

  • Study site

    Santiago

  • Study site

    Valdivia

Other trials in Chile

Colombia2 sites

  • Study site

    Bogotá, NAP

  • Study site

    Bogotá

Other trials in Colombia

Finland2 sites

  • Study site

    Kuopio, 70210

  • Study site

    Turku, 20520

Other trials in Finland

France2 sites

  • Study site

    Strasbourg, 67000

  • Study site

    Tourcoing, 59200

Other trials in France

Peru2 sites

  • Study site

    Lima, Lima 11

  • Study site

    Lima, Lima 31

Other trials in Peru

Portugal2 sites

  • Study site

    Lisbon, 1169-050

  • Study site

    Lisbon, 1495-005

Other trials in Portugal

Switzerland2 sites

  • Study site

    Basel, CH 4031

  • Study site

    Geneva, CH 1211

Other trials in Switzerland

Taiwan2 sites

  • Study site

    Tainan

  • Study site

    Taoyuan Hsien

Other trials in Taiwan

Austria1 site

  • Study site

    Vienna, 1100

Other trials in Austria

Denmark1 site

  • Study site

    Odense, 5000

Other trials in Denmark

Panama1 site

  • Study site

    Panama City, 907

Other trials in Panama

About this study

Official title: A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline Versus Ertapenem for the Treatment of Foot Infections in Subjects With Diabetes

The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.

Being tested
Tigecycline, Ertapenem
Keywords
Diabetic foot infection, Osteomyelitis, Diabetes Complications, Foot ulcer, Skin infection
Medical subject headings
Bacterial Infections, Diabetic Foot, Osteomyelitis, Diabetes Complications, Foot Ulcer, Cellulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TigecyclineDrug

    150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis

  • ErtapenemDrug

    Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).

Study groups in NCT00366249
Study groupRoleWhat they receive
AActive comparatorNot described
Receives: Drug: Tigecycline
BActive comparatorNot described
Receives: Drug: Ertapenem

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Clinical Response of Cure Vs. Failure.

    Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) > 48 hrs.

    Measured: Test of cure visit (TOC): Assessed at least 12 days post last dose

  2. Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.

    Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.

    Measured: Test of cure visit (TOC): Assessed at least 12 days post last dose

Secondary outcomes (3)

  1. Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.

    Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.

    Measured: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose

  2. Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.

    Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.

    Measured: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose

  3. Number of Patients With Microbiologic Response of Eradication.

    Eradication defined as: no pathogen is present in the repeat culture from the original site of infection, or a clinical response of the cure precludes the availability of a specimen for culture.

    Measured: Test of cure visit (TOC): Assessed at least 12 days post last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,061 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00366249
Sponsor's protocol ID
3074K5-319
Status last verified
Apr 2010
First submitted
17 Aug 2006
Last updated
28 Apr 2010
Data monitoring committee
Yes

Publications

  • Lauf L, Ozsvar Z, Mitha I, Regoly-Merei J, Embil JM, Cooper A, Sabol MB, Castaing N, Dartois N, Yan J, Dukart G, Maroko R. Phase 3 study comparing tigecycline and ertapenem in patients with diabetic foot infections with and without osteomyelitis. Diagn Microbiol Infect Dis. 2014 Apr;78(4):469-80. doi: 10.1016/j.diagmicrobio.2013.12.007. Epub 2013 Dec 16.

    PubMed 24439136

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tigecycline and Ertapenem in people with Bacterial Infections and Diabetic Foot, run by Wyeth is now a wholly owned subsidiary of Pfizer at 211 sites in 39 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in Argentina, United States, Russia, Mexico, Canada and 34 more countries. 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?

Yes. Results are posted in the registry (first posted 21 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients With Clinical Response of Cure Vs. Failure. (time frame: Test of cure visit (TOC): Assessed at least 12 days post last dose). The study lists 2 primary outcomes in all. 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 NCT00366249, which also lists 1 linked publication.

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 28 Apr 2010.

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