Trial · NCT02736968
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia and Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours) | Day 5 | Diarrhea was assessed by self-report at each study visit. Resolution of diarrhea occurred when participants reported less than 3 loose stools in 24 hours. |
| Primary | Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test) | Day 5 | Participants provided stool samples on Day 5. Stool samples were assessed for parasitological response by detection of cysts or trophozoites via microscopic exam or a negative antigen test. |
| Secondary | Proportion of Participants With Negative Giardia Stool Antigens | Day 3 through Day 5 | Participants provided stool samples on Days 3 and 5. Stool samples were tested for Giardia using antigen detection EIA. Proportions are calculated as the number of participants with negative Giardia stool antigen tests divided by the number of participants with results available. |
| Secondary | Proportion of Symptomatic Participants With Positive Rapid EIA and Positive Antigen Detection EIA for Giardia and Trophozoites on Smear at Enrollment With Parasitological Response | Day 3 through Day 5 | Participants provided stool samples on Days 3 and 5. Stool samples were assessed for parasitological response by detection of trophozoites via microscopic exam. Proportions are calculated as the number of participants with parasitological response divided by the number of participants with results available. |
| Secondary | Proportion of Symptomatic Participants With Sustained Giardia Cure (no Detection of Trophozoites by Microscopic Exam) | Day 14 through Day 28 | Participants provided stool samples on Days 14 and 28. Stool samples were assessed for sustained Giardia cure by detection of trophozoites via microscopic exam. Proportion is calculated as the number of participants with sustained cure divided by the number of participants with results available. |
| Secondary | Giardia Trophozoite/Cyst Load by Quantitative Polymerase Chain Reaction (qPCR) in Stools of Symptomatic Participants | Day 3 through Day 5 | Participants provided stool samples on Days 3 and 5. The Giardia trophozoite/cyst load (parasites/uL) for each group was then assessed by Quantitative Polymerase Chain Reaction (qPCR). |
| Secondary | Time to Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours) | Day 1 through Day 28 | Diarrhea was assessed by self-report at each study visit. Resolution of diarrhea occurred when participants reported less than 3 loose stools in 24 hours. |
| Secondary | Proportion of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test) | Day 3 | Participants provided stool samples on Day3. Stool samples were assessed for parasitological response by detection of cysts or trophozoites via microscopic exam or a negative antigen test. Proportions are calculated as the number of participants with parasitological response divided by the number of participants with results available. |
| Secondary | Giardia Trophozoite/Cyst Load by Quantitative Polymerase Chain Reaction (qPCR) in Stools | Day 3 through Day 5 | Participants provided stool samples on Days 3 and 5. The Giardia trophozoite/cyst load (parasites/uL) for each group was then assessed by Quantitative Polymerase Chain Reaction (qPCR). |
| Secondary | Proportion of Asymptomatic Participants With Sustained Giardia Cure (no Detection of Trophozoites by Microscopic Exam) | Day 14 through Day 28 | Participants provided stool samples on Days 14 and 28. Stool samples were assessed for sustained Giardia cure by detection of cysts or trophozoites via microscopic exam or negative antigen detection. Proportions are calculated as the number of participants with sustained cure divided by the number of participants with results available. |
| Secondary | Proportion of Participants With Relapse (Same Strain) or Re-infection (New Strain) With Giardia-positive Stools by Genotyping the Initial vs. Subsequent Strain | Day 14 through Day 28 | Participants provided stool samples on Days 14 and 28. Any stool that was still positive for Giardia or trophozoites at Days 14 and 28 had DNA genotyping of the parasite performed on de-identified specimens of extracted DNA. The genotypes from initial and final isolates were compared to determine relapse and/or re-infection. Proportion is calculated as the number of participants with relapse or re-infection divided by the number of participants with results available. |
| Secondary | Proportion of Participants With Relapse (Same Strain) or Re-infection (New Strain) With Giardia-positive Stools by Genotyping the Initial vs. Subsequent Strain | Day 1 through Day 28 | Participants provided stool samples on Days 1, 14 and 28. Participants that were positive for Giardia via antigen detection at Day 1 and had a negative antigen detection test followed by a positive antigen detection test had DNA genotyping of the parasite performed on de-identified specimens of extracted DNA. The genotypes from initial (Day 1) and final isolates (Day 14/28) were compared to determine relapse and/or re-infection. Proportion is calculated as the number of participants with relapse or re-infection divided by the number of participants with results available. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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