Efficacy and Safety of Teicoplanin in CDAD

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Sanofi
Send
Updated on 19 February 2024
See if I qualify

Summary

Primary Objective:

Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis

Secondary Objective:

Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis

Description

Approximate 10 weeks

Details
Condition Clostridium Difficile Infection-associated Diarrhea and Colitis
Age 18years - 100years
Treatment TEICOPLANIN
Clinical Study IdentifierNCT04003818
SponsorSanofi
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Signed Informed Consent
Male or female no less than 18 years of age
Inpatient with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid or unformed bowel movements (UBM) within 24 hours prior to enrollment, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to enrollment

Exclusion Criteria

More than one previous episode of CDAD in the 3-month period prior to enrollment
Evidence of life-threatening or fulminant CDAD
Likelihood of death within 72 hours from any cause
History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea
Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF)
Known hypersensitivity or contraindication to teicoplanin
Pregnant or nursing females
Unable or unwilling to comply with all protocol requirements
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
The above information is not intended to contain all considerations relevant
to a patient's potential participation in a clinical trial
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center

Select a site

Enter your location to find study centers near you

Entire World

study centers available

    loading...

Send a message

Enter your contact details to connect with study team

First name*
Last name*
Email*
Phone number*
  • United States+1
  • United Kingdom+44
  • Afghanistan (‫افغانستان‬‎)+93
  • Albania (Shqipëri)+355
  • Algeria (‫الجزائر‬‎)+213
  • American Samoa+1
  • Andorra+376
  • Angola+244
  • Anguilla+1
  • Antigua and Barbuda+1
  • Argentina+54
  • Armenia (Հայաստան)+374
  • Aruba+297
  • Ascension Island+247
  • Australia+61
  • Austria (Österreich)+43
  • Azerbaijan (Azərbaycan)+994
  • Bahamas+1
  • Bahrain (‫البحرين‬‎)+973
  • Bangladesh (বাংলাদেশ)+880
  • Barbados+1
  • Belarus (Беларусь)+375
  • Belgium (België)+32
  • Belize+501
  • Benin (Bénin)+229
  • Bermuda+1
  • Bhutan (འབྲུག)+975
  • Bolivia+591
  • Bosnia and Herzegovina (Босна и Херцеговина)+387
  • Botswana+267
  • Brazil (Brasil)+55
  • British Indian Ocean Territory+246
  • British Virgin Islands+1
  • Brunei+673
  • Bulgaria (България)+359
  • Burkina Faso+226
  • Burundi (Uburundi)+257
  • Cambodia (កម្ពុជា)+855
  • Cameroon (Cameroun)+237
  • Canada+1
  • Cape Verde (Kabu Verdi)+238
  • Caribbean Netherlands+599
  • Cayman Islands+1
  • Central African Republic (République centrafricaine)+236
  • Chad (Tchad)+235
  • Chile+56
  • China (中国)+86
  • Christmas Island+61
  • Cocos (Keeling) Islands+61
  • Colombia+57
  • Comoros (‫جزر القمر‬‎)+269
  • Congo (DRC) (Jamhuri ya Kidemokrasia ya Kongo)+243
  • Congo (Republic) (Congo-Brazzaville)+242
  • Cook Islands+682
  • Costa Rica+506
  • Côte d’Ivoire+225
  • Croatia (Hrvatska)+385
  • Cuba+53
  • Curaçao+599
  • Cyprus (Κύπρος)+357
  • Czech Republic (Česká republika)+420
  • Denmark (Danmark)+45
  • Djibouti+253
  • Dominica+1
  • Dominican Republic (República Dominicana)+1
  • Ecuador+593
  • Egypt (‫مصر‬‎)+20
  • El Salvador+503
  • Equatorial Guinea (Guinea Ecuatorial)+240
  • Eritrea+291
  • Estonia (Eesti)+372
  • Eswatini+268
  • Ethiopia+251
  • Falkland Islands (Islas Malvinas)+500
  • Faroe Islands (Føroyar)+298
  • Fiji+679
  • Finland (Suomi)+358
  • France+33
  • French Guiana (Guyane française)+594
  • French Polynesia (Polynésie française)+689
  • Gabon+241
  • Gambia+220
  • Georgia (საქართველო)+995
  • Germany (Deutschland)+49
  • Ghana (Gaana)+233
  • Gibraltar+350
  • Greece (Ελλάδα)+30
  • Greenland (Kalaallit Nunaat)+299
  • Grenada+1
  • Guadeloupe+590
  • Guam+1
  • Guatemala+502
  • Guernsey+44
  • Guinea (Guinée)+224
  • Guinea-Bissau (Guiné Bissau)+245
  • Guyana+592
  • Haiti+509
  • Honduras+504
  • Hong Kong (香港)+852
  • Hungary (Magyarország)+36
  • Iceland (Ísland)+354
  • India (भारत)+91
  • Indonesia+62
  • Iran (‫ایران‬‎)+98
  • Iraq (‫العراق‬‎)+964
  • Ireland+353
  • Isle of Man+44
  • Israel (‫ישראל‬‎)+972
  • Italy (Italia)+39
  • Jamaica+1
  • Japan (日本)+81
  • Jersey+44
  • Jordan (‫الأردن‬‎)+962
  • Kazakhstan (Казахстан)+7
  • Kenya+254
  • Kiribati+686
  • Kosovo+383
  • Kuwait (‫الكويت‬‎)+965
  • Kyrgyzstan (Кыргызстан)+996
  • Laos (ລາວ)+856
  • Latvia (Latvija)+371
  • Lebanon (‫لبنان‬‎)+961
  • Lesotho+266
  • Liberia+231
  • Libya (‫ليبيا‬‎)+218
  • Liechtenstein+423
  • Lithuania (Lietuva)+370
  • Luxembourg+352
  • Macau (澳門)+853
  • Madagascar (Madagasikara)+261
  • Malawi+265
  • Malaysia+60
  • Maldives+960
  • Mali+223
  • Malta+356
  • Marshall Islands+692
  • Martinique+596
  • Mauritania (‫موريتانيا‬‎)+222
  • Mauritius (Moris)+230
  • Mayotte+262
  • Mexico (México)+52
  • Micronesia+691
  • Moldova (Republica Moldova)+373
  • Monaco+377
  • Mongolia (Монгол)+976
  • Montenegro (Crna Gora)+382
  • Montserrat+1
  • Morocco (‫المغرب‬‎)+212
  • Mozambique (Moçambique)+258
  • Myanmar (Burma) (မြန်မာ)+95
  • Namibia (Namibië)+264
  • Nauru+674
  • Nepal (नेपाल)+977
  • Netherlands (Nederland)+31
  • New Caledonia (Nouvelle-Calédonie)+687
  • New Zealand+64
  • Nicaragua+505
  • Niger (Nijar)+227
  • Nigeria+234
  • Niue+683
  • Norfolk Island+672
  • North Korea (조선 민주주의 인민 공화국)+850
  • North Macedonia (Северна Македонија)+389
  • Northern Mariana Islands+1
  • Norway (Norge)+47
  • Oman (‫عُمان‬‎)+968
  • Pakistan (‫پاکستان‬‎)+92
  • Palau+680
  • Palestine (‫فلسطين‬‎)+970
  • Panama (Panamá)+507
  • Papua New Guinea+675
  • Paraguay+595
  • Peru (Perú)+51
  • Philippines+63
  • Poland (Polska)+48
  • Portugal+351
  • Puerto Rico+1
  • Qatar (‫قطر‬‎)+974
  • Réunion (La Réunion)+262
  • Romania (România)+40
  • Russia (Россия)+7
  • Rwanda+250
  • Saint Barthélemy+590
  • Saint Helena+290
  • Saint Kitts and Nevis+1
  • Saint Lucia+1
  • Saint Martin (Saint-Martin (partie française))+590
  • Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon)+508
  • Saint Vincent and the Grenadines+1
  • Samoa+685
  • San Marino+378
  • São Tomé and Príncipe (São Tomé e Príncipe)+239
  • Saudi Arabia (‫المملكة العربية السعودية‬‎)+966
  • Senegal (Sénégal)+221
  • Serbia (Србија)+381
  • Seychelles+248
  • Sierra Leone+232
  • Singapore+65
  • Sint Maarten+1
  • Slovakia (Slovensko)+421
  • Slovenia (Slovenija)+386
  • Solomon Islands+677
  • Somalia (Soomaaliya)+252
  • South Africa+27
  • South Korea (대한민국)+82
  • South Sudan (‫جنوب السودان‬‎)+211
  • Spain (España)+34
  • Sri Lanka (ශ්‍රී ලංකාව)+94
  • Sudan (‫السودان‬‎)+249
  • Suriname+597
  • Svalbard and Jan Mayen+47
  • Sweden (Sverige)+46
  • Switzerland (Schweiz)+41
  • Syria (‫سوريا‬‎)+963
  • Taiwan (台灣)+886
  • Tajikistan+992
  • Tanzania+255
  • Thailand (ไทย)+66
  • Timor-Leste+670
  • Togo+228
  • Tokelau+690
  • Tonga+676
  • Trinidad and Tobago+1
  • Tunisia (‫تونس‬‎)+216
  • Turkey (Türkiye)+90
  • Turkmenistan+993
  • Turks and Caicos Islands+1
  • Tuvalu+688
  • U.S. Virgin Islands+1
  • Uganda+256
  • Ukraine (Україна)+380
  • United Arab Emirates (‫الإمارات العربية المتحدة‬‎)+971
  • United Kingdom+44
  • United States+1
  • Uruguay+598
  • Uzbekistan (Oʻzbekiston)+998
  • Vanuatu+678
  • Vatican City (Città del Vaticano)+39
  • Venezuela+58
  • Vietnam (Việt Nam)+84
  • Wallis and Futuna (Wallis-et-Futuna)+681
  • Western Sahara (‫الصحراء الغربية‬‎)+212
  • Yemen (‫اليمن‬‎)+967
  • Zambia+260
  • Zimbabwe+263
  • Åland Islands+358

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.