Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea
NCT ID: NCT01618591
Last Updated: 2016-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
384 participants
INTERVENTIONAL
2012-09-30
2016-03-31
Brief Summary
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Detailed Description
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For the ADF arm, patients will be randomized to receive 1 of 2 regimens: (1) azithromycin 1000 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days (75 subjects); or (2) azithromycin 1000 mg as a single dose without loperamide (75 subjects).
Study Procedures (Brief): Baseline exam as well as blood and stool samples will be collected at initial clinic visit. Clinical assessments will be performed at 24 hours, 72 hours, and 7 days. In addition, microbiological cure will be evaluated at 7-d post initiation of treatment. Subjects will have blood drawn to assess for serological conversion to common enteric pathogens, and stool collected at 7- and 21-d . Subjects may also opt in for long-term follow-up at time of enrollment, which will assess for development of post-infectious functional bowel disorders. All subjects will complete a baseline assessment at 7-d visit, and those who opt for the additional follow-up will complete a series of web-based surveys at 3-, 6-, 9-, and 12-m post enrollment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acute Watery Diarrhea
Single dose rifaximin 1650 mg
Rifaximin 1650 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
Single dose azithromycin 500 mg
Azithromycin 500 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
Single dose levofloxacin 500 mg
Levofloxacin 500 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
Acute Dysentery/Febrile
Single dose azithromycin 1000 mg plus loperamide
Azithromycin 1000 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
Single dose azithromycin 1000 mg plus placebo
Azithromycin 1000 mg as a single dose and placebo in lieu of loperamide
Interventions
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Single dose rifaximin 1650 mg
Rifaximin 1650 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
Single dose azithromycin 500 mg
Azithromycin 500 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
Single dose levofloxacin 500 mg
Levofloxacin 500 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
Single dose azithromycin 1000 mg plus loperamide
Azithromycin 1000 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
Single dose azithromycin 1000 mg plus placebo
Azithromycin 1000 mg as a single dose and placebo in lieu of loperamide
Eligibility Criteria
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Inclusion Criteria
2. Presence of acute diarrhea (3 or more stools in 24 hours or 2 or more stools in 24 hours and associated symptoms such as nausea, vomiting, abdominal cramps or tenesmus) and \<96 hours duration.
3. Eligible for ambulatory management.
4. Able to comply with follow-up procedures.
5. Will remain in country for at least 7 days
Exclusion Criteria
2. Antibiotic therapy in the 72 hours prior to presentation (excluding malaria prophylaxis with mefloquine, malarone, chloroquine/proguanil, or doxycycline).
3. Concomitant medications with known drug-drug interactions with any of the study drugs (includes theophylline, digoxin, and warfarin).
4. History of seizures (relative contraindication to quinolones)
5. Positive pregnancy test at presentation (contraindicated with fluoroquinolone therapy). All female subjects will be administered a urine pregnancy test prior to enrollment.
6. Presence of symptoms \>96 hours prior to initiating treatment.
7. Use of \>4 mg loperamide or use of any amount of loperamide for greater than 24 hours prior to enrollment.
18 Years
ALL
No
Sponsors
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Navy Bureau of Medicine and Surgery
FED
Ministry of Defence, United Kingdom
OTHER_GOV
Naval Medical Research Center
FED
Naval Medical Research Unit- 3
FED
United States Army Medical Unit - Kenya
FED
United States Naval Medical Center, Portsmouth
FED
Naval Medical Research Unit- 6
FED
Uniformed Services University of the Health Sciences
FED
Responsible Party
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Mark Riddle, CDR, MC, USN
Head, Enteric Diseases Department
Principal Investigators
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Mark Riddle, MD, DrPH
Role: PRINCIPAL_INVESTIGATOR
Naval Medical Research Center
Locations
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UK Role 3 Joint Force Hospital
Camp Bastion Air Base, , Afghanistan
U.S. Naval Expeditionary Base
Camp Lemonnier, , Djibouti
Joint Task Force - Bravo
Soto Cano Air Base, , Honduras
British Army Training Unit Kenya
Nanyuki, , Kenya
Armed Forces Research Institute of Medical Sciences
Bangkok, , Thailand
Countries
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References
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Johnson RC, Van Nostrand JD, Tisdale M, Swierczewski B, Simons MP, Connor P, Fraser J, Melton-Celsa AR, Tribble DR, Riddle MS. Fecal Microbiota Functional Gene Effects Related to Single-Dose Antibiotic Treatment of Travelers' Diarrhea. Open Forum Infect Dis. 2021 May 28;8(6):ofab271. doi: 10.1093/ofid/ofab271. eCollection 2021 Jun.
Riddle MS, Connor P, Fraser J, Porter CK, Swierczewski B, Hutley EJ, Danboise B, Simons MP, Hulseberg C, Lalani T, Gutierrez RL, Tribble DR; TrEAT TD Study Team. Trial Evaluating Ambulatory Therapy of Travelers' Diarrhea (TrEAT TD) Study: A Randomized Controlled Trial Comparing 3 Single-Dose Antibiotic Regimens With Loperamide. Clin Infect Dis. 2017 Nov 29;65(12):2008-2017. doi: 10.1093/cid/cix693.
Other Identifiers
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IDCRP-065
Identifier Type: -
Identifier Source: org_study_id