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The purpose of this Phase I controlled human infection model (CHIM) study was to determine if oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum oocysts (ABO809) to healthy volunteers resulted in a Cryptosporidium infection and diarrheal illness. The study measured fecal oocysts (parasitological endpoint) as well as diarrhea and associated signs and symptoms (clinical endpoint).
This study was funded by the Wellcome Trust. This Phase 1 Cryptosporidium controlled human infection model (CHIM) study employed a single-center, open-label design to characterize the incidence of infection and associated symptoms following the administration of single doses of Cryptosporidium parvum oocysts (CE).
Healthy volunteers were enrolled in cohorts of approximately 10 participants who received ABO809 on the same day (Day 1). The study consisted of three sequential cohorts which were dosed one after the other for a total of 30 participants. A dose level group received the same ABO809 dose and could be comprised of multiple cohorts. The first dose level group started with a cohort of 10 participants who received ABO809 at a dose of 1x10^4 oocysts. The study continued to enroll participants in the same dose level group if the desired incidences of infection and diarrheal illness were observed, up to a total of approximately 30 participants. If the desired incidences of infection and diarrheal illness were not observed, a new dose level group, receiving ABO809 at a dose of 1x10^6 oocysts, could be initiated. If needed to optimize the model, intermediate ABO809 doses could be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABO809 | Experimental | Participants will receive ABO809 at a single oral dose of 1x10^4 oocysts. Other doses such as 1x10^6 oocysts may be considered to optimize the model |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryptosporidium parvum oocysts (ABO809) | Biological | ABO809 3x10^6 CE/3mL concentrate for oral suspension, single dose at Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Cryptosporidium Infection From 72 Hours to 10 Days Post ABO809 Oral Administration | Cryptosporidium infection was measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. Up to 3 stool samples per day were collected, each separated by approximately 4-hour intervals, were analyzed by EIA for parasitological assessment of oocyst shedding. | At ≥72 hours post-administration (or sooner if associated with symptoms suggestive of diarrheal illness) up to Day 10 (inclusive). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Showing Clinical Diarrheal Illness From Day 1 to Day 28 Post ABO809 Oral Administration | Clinical diarrheal illness was defined as the occurrence of at least two diarrheal bowel events within 24 hours on at least two days after the administration of ABO809. Diarrhea is defined as at least one stool sample grading 3-5 on the Stool Grading system in one day. Grades 1 and 2 are considered normal stool and Grades 3-5 are considered diarrheal stool. Grade 1 stool is defined as formed stool which does not take the shape of the container. Grade 2 stool is defined as soft stool which does not easily take the shape of the container. Grade 3 diarrheal stool is defined as thick liquid stool taking the shape of the container. Grade 4 diarrheal stool is defined as opaque watery stool. Grade 5 diarrheal stool is defined as rice water or clear watery stools. |
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Inclusion Criteria:
Exclusion Criteria:
- History of Cryptosporidium infection, gastrointestinal conditions (including diarrheal syndromes, gastroenteritis and gastrointestinal tract surgery), immunodeficiency, infections, significant medical concerns, hypersensitivity to nitazoxanide or other specified antibiotics.
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Al-Ibrahim | Pharmaron CPC, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42201116 | Derived | Stuart BD, Stevenson K, Tillmann HC, Middleton C, Nguyen A, Jumani RS, Zhao X, Blais J, Braud-Perez S, Zhang Y, Etse J, Arora K, Aziz N, Mohamed AI, Diagana TT, Manjunatha UH. Development of a Phase 1 Cryptosporidiosis Controlled Human Challenge Model in Healthy Volunteers Using Current Good Manufacturing Practice Cryptosporidium Parvum Oocysts and Conducted Under an Investigational New Drug Application. J Infect Dis. 2026 May 27:jiag246. doi: 10.1093/infdis/jiag246. Online ahead of print. |
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Participants took part in one investigative site in one country.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABO809 1x10^4 CE-Cohort 1 | ABO809 single oral dose of 1x10^4 oocysts. |
| FG001 | ABO809 1x10^6 CE-Cohort 2 | ABO809 single oral dose of 1x10^6 oocysts. |
| FG002 | ABO809 1x10^6 CE-Cohort 3 | ABO809 single oral dose of 1x10^6 oocysts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ABO809 1x10^4 CE-Cohort 1 | ABO809 single oral dose of 1x10^4 oocysts. |
| BG001 | ABO809 1x10^6 CE-Cohort 2 | ABO809 single oral dose of 1x10^6 oocysts. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Cryptosporidium Infection From 72 Hours to 10 Days Post ABO809 Oral Administration | Cryptosporidium infection was measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. Up to 3 stool samples per day were collected, each separated by approximately 4-hour intervals, were analyzed by EIA for parasitological assessment of oocyst shedding. | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. | Posted | Number | 80% Confidence Interval | percentage of participants | At ≥72 hours post-administration (or sooner if associated with symptoms suggestive of diarrheal illness) up to Day 10 (inclusive). |
|
Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABO809 1x10^4 CE - Cohort 1 | ABO809 single oral dose of 1x10^4 oocysts. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 2, 2021 | Nov 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2023 | Nov 14, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003457 | Cryptosporidiosis |
| ID | Term |
|---|---|
| D007411 | Intestinal Diseases, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D011529 | Protozoan Infections, Animal |
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Cryptosporidium controlled human infection model
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Open-Label
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| From Day 1 up to Day 28 |
| Number of Diarrhea Stools Per Participant | Diarrhea is defined as at least one stool sample grading 3-5 on the Stool Grading system in one day. Grades 1 and 2 are considered normal stool and Grades 3-5 are considered diarrheal stool. Grade 1 stool is defined as formed stool which does not take the shape of the container. Grade 2 stool is defined as soft stool which does not easily take the shape of the container. Grade 3 diarrheal stool is defined as thick liquid stool taking the shape of the container. Grade 4 diarrheal stool is defined as opaque watery stool. Grade 5 diarrheal stool is defined as rice water or clear watery stools. | From Day 1 up to Day 28 |
| Overall Diarrheal Stool Weight | Stool weight in grams of each stool from each participant were measured during inpatient period from Day 1 up to Day 10. Stool weight in grams of stool collected 24 hours prior to outpatient visit from each participant were measured during outpatient period from Day 14 to Day 28. | From Day 1 up to Day 28 |
| Maximum Stool Grade by Stool Grade Category | All collected stool samples were graded according to the Stool Grading system. Grades 1 and 2 are considered normal stool and Grades 3-5 are considered diarrheal stool. Grades 3-5 stools are defined as thick liquid diarrhea taking the shape of the container, opaque watery, rice water or clear watery stools. The maximum stool grade is the highest stool grade of all episodes in a participant. | From Day 1 up to Day 28 |
| Time to Onset of Clinical Diarrheal Illness | Clinical diarrheal illness was defined as the occurrence of at least two diarrheal bowel events within 24 hours on at least two days after the administration of ABO809. The time to onset is the number of days until the start diarrheal illness. | From Day 1 up to Day 28 |
| Time to Resolution of Clinical Diarrheal Illness | Clinical diarrheal illness was defined as the occurrence of at least two diarrheal bowel events within 24 hours on at least two days after the administration of ABO809. The time to resolution is the number of days until the resolution of diarrheal illness, which is defined as 2 or more consecutive days with no diarrheal stools (stool grades 1 or 2). | From Day 1 up to Day 28 |
| Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness | Clinical signs and symptoms associated with clinical diarrheal illness such as: abdominal pain, abdominal cramping, nausea, vomiting, fever, electrolyte disbalance, dehydration. | From Day 1 up to Day 28 |
| Percentage of Participants With Cryptosporidium Infection From 72 Hours to Day 28 Post ABO809 Oral Administration | Percentage of participants with Cryptosporidium infection following an oral administration of ABO809. Cryptosporidium infection were measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. | From 72 hours post-administration up to Day 28 |
| Percentage of Participants With Fecal Shedding of Cryptosporidium Parvum Oocysts | Percentage of participants with fecal shedding of Cryptosporidium parvum oocysts following an oral administration of ABO809. Fecal shedding will be measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. | From 72 hours post-administration up to Day 28 |
| Time to Onset of Cryptosporidium Infection | Time to onset is the number of days until the start of Cryptosporidium infection which were measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. | From Day 1 up to Day 10 |
| Time to Resolution of Cryptosporidium Infection | Time to resolution is the number of days until the resolution of Cryptosporidium infection in participants who developed an infection following an oral administration of ABO809. Resolution of Cryptosporidium infection is defined as no evidence of Cryptosporidium in stool samples collected over ≥2 consecutive days. | From Day 1 up to Day 28 |
| Number of Participants With Adverse Events of Special Interest (AESIs) | The following adverse events associated with Cryptosporidium infection are considered AESIs in this trial: Gastroenteritis in the absence of Cryptosporidium infection, extraintestinal cryptosporidiosis, persistent or recurrent cryptosporidiosis, persistent cryptosporidium shedding, moderate or severe dehydration and non-intestinal sequelae including eye pain or joint pain. | Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days. |
| BG002 | ABO809 1x10^6 CE-Cohort 3 | ABO809 single oral dose of 1x10^6 oocysts. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | ABO809 1x10^6 CE-Cohort 2 | ABO809 single oral dose of 1x10^6 oocysts. |
| OG002 | ABO809 1x10^6 CE-Cohort 3 | ABO809 single oral dose of 1x10^6 oocysts. |
|
|
| Secondary | Percentage of Participants Showing Clinical Diarrheal Illness From Day 1 to Day 28 Post ABO809 Oral Administration | Clinical diarrheal illness was defined as the occurrence of at least two diarrheal bowel events within 24 hours on at least two days after the administration of ABO809. Diarrhea is defined as at least one stool sample grading 3-5 on the Stool Grading system in one day. Grades 1 and 2 are considered normal stool and Grades 3-5 are considered diarrheal stool. Grade 1 stool is defined as formed stool which does not take the shape of the container. Grade 2 stool is defined as soft stool which does not easily take the shape of the container. Grade 3 diarrheal stool is defined as thick liquid stool taking the shape of the container. Grade 4 diarrheal stool is defined as opaque watery stool. Grade 5 diarrheal stool is defined as rice water or clear watery stools. | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. | Posted | Number | 80% Confidence Interval | percentage of participants | From Day 1 up to Day 28 |
|
|
|
| Secondary | Number of Diarrhea Stools Per Participant | Diarrhea is defined as at least one stool sample grading 3-5 on the Stool Grading system in one day. Grades 1 and 2 are considered normal stool and Grades 3-5 are considered diarrheal stool. Grade 1 stool is defined as formed stool which does not take the shape of the container. Grade 2 stool is defined as soft stool which does not easily take the shape of the container. Grade 3 diarrheal stool is defined as thick liquid stool taking the shape of the container. Grade 4 diarrheal stool is defined as opaque watery stool. Grade 5 diarrheal stool is defined as rice water or clear watery stools. | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Error | diarrheal stools | From Day 1 up to Day 28 |
|
|
|
| Secondary | Overall Diarrheal Stool Weight | Stool weight in grams of each stool from each participant were measured during inpatient period from Day 1 up to Day 10. Stool weight in grams of stool collected 24 hours prior to outpatient visit from each participant were measured during outpatient period from Day 14 to Day 28. | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | grams | From Day 1 up to Day 28 |
|
|
|
| Secondary | Maximum Stool Grade by Stool Grade Category | All collected stool samples were graded according to the Stool Grading system. Grades 1 and 2 are considered normal stool and Grades 3-5 are considered diarrheal stool. Grades 3-5 stools are defined as thick liquid diarrhea taking the shape of the container, opaque watery, rice water or clear watery stools. The maximum stool grade is the highest stool grade of all episodes in a participant. | Posted | Count of Participants | Participants | From Day 1 up to Day 28 |
|
|
|
| Secondary | Time to Onset of Clinical Diarrheal Illness | Clinical diarrheal illness was defined as the occurrence of at least two diarrheal bowel events within 24 hours on at least two days after the administration of ABO809. The time to onset is the number of days until the start diarrheal illness. | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | days | From Day 1 up to Day 28 |
|
|
|
| Secondary | Time to Resolution of Clinical Diarrheal Illness | Clinical diarrheal illness was defined as the occurrence of at least two diarrheal bowel events within 24 hours on at least two days after the administration of ABO809. The time to resolution is the number of days until the resolution of diarrheal illness, which is defined as 2 or more consecutive days with no diarrheal stools (stool grades 1 or 2). | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | days | From Day 1 up to Day 28 |
|
|
|
| Secondary | Percentage of Participants With Characteristics of Clinical Signs and Symptoms Associated With Clinical Diarrheal Illness | Clinical signs and symptoms associated with clinical diarrheal illness such as: abdominal pain, abdominal cramping, nausea, vomiting, fever, electrolyte disbalance, dehydration. | Safety analysis set (SAF) included all participants that received one dose of ABO809 during the treatment period. | Posted | Count of Participants | Participants | From Day 1 up to Day 28 |
|
|
|
| Secondary | Percentage of Participants With Cryptosporidium Infection From 72 Hours to Day 28 Post ABO809 Oral Administration | Percentage of participants with Cryptosporidium infection following an oral administration of ABO809. Cryptosporidium infection were measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. | Posted | Number | 80% Confidence Interval | percentage of participants | From 72 hours post-administration up to Day 28 |
|
|
|
| Secondary | Percentage of Participants With Fecal Shedding of Cryptosporidium Parvum Oocysts | Percentage of participants with fecal shedding of Cryptosporidium parvum oocysts following an oral administration of ABO809. Fecal shedding will be measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. | Posted | Number | 80% Confidence Interval | percentage of participants | From 72 hours post-administration up to Day 28 |
|
|
|
| Secondary | Time to Onset of Cryptosporidium Infection | Time to onset is the number of days until the start of Cryptosporidium infection which were measured by examining the presence of a Cryptosporidium antigen in stool using a commercially available diagnostic Enzyme Immunoassay (EIA) test. | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. Only participants with an actual infection were included in the analysis. | Posted | Mean | Standard Deviation | days | From Day 1 up to Day 10 |
|
|
|
| Secondary | Time to Resolution of Cryptosporidium Infection | Time to resolution is the number of days until the resolution of Cryptosporidium infection in participants who developed an infection following an oral administration of ABO809. Resolution of Cryptosporidium infection is defined as no evidence of Cryptosporidium in stool samples collected over ≥2 consecutive days. | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. Only participants with an actual infection were included in the analysis. | Posted | Mean | Standard Deviation | days | From Day 1 up to Day 28 |
|
|
|
| Secondary | Number of Participants With Adverse Events of Special Interest (AESIs) | The following adverse events associated with Cryptosporidium infection are considered AESIs in this trial: Gastroenteritis in the absence of Cryptosporidium infection, extraintestinal cryptosporidiosis, persistent or recurrent cryptosporidiosis, persistent cryptosporidium shedding, moderate or severe dehydration and non-intestinal sequelae including eye pain or joint pain. | The pharmacodynamic (PD) analysis set included all participants with available parasitological and clinical data and with no protocol deviations with relevant impact on PD data. | Posted | Count of Participants | Participants | No | Adverse events were reported from oral administration of ABO809 up to a maximum duration of 56 days. |
|
|
|
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | ABO809 1x10^6 CE-Cohort 2 | ABO809 single oral dose of 1x10^6 oocysts. | 0 | 10 | 0 | 10 | 9 | 10 |
| EG002 | ABO809 1x10^6 CE-Cohort 3 | ABO809 single oral dose of 1x10^6 oocysts. | 0 | 10 | 0 | 10 | 9 | 10 |
| EG003 | ABO809 1x10^6 CE - Cohorts 2 and 3 | ABO809 single oral dose of 1x10^6 oocysts. | 0 | 20 | 0 | 20 | 18 | 20 |
| EG004 | Total | Total | 0 | 30 | 0 | 30 | 28 | 30 |
| Tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Defaecation urgency | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Rectal tenesmus | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Occult blood | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D010273 | Parasitic Diseases, Animal |
| D003048 | Coccidiosis |
| D011528 | Protozoan Infections |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D000820 | Animal Diseases |
| Clinical diarrheal illness up to Day 28 (inclusive) |
|
| Title | Measurements |
|---|---|
|
| Stool Grade 1 and 2 |
|
| Stool Grade 3 |
|
| Stool Grade 4 |
|
| Stool Grade 5 |
|
| Stool Grade >= 3 |
|
|
| Abdominal pain |
|
| Abdominal tenderness |
|
| Defaecation urgency |
|
| Flatulence |
|
| Haematochezia |
|
| Nausea |
|
| Rectal tenesmus |
|
| Vomiting |
|
| Pyrexia |
|
| Occult blood |
|
| Occult blood positive |
|
| Decreased appetite |
|
| Dehydration |
|
|
| Gastroenteritis in the absence of Cryptosporidium infection |
|
| Extraintestinal cryptosporidiosis |
|
| Persistent or recurrent cryptosporidosis |
|
| Persistent cryptosporidium shedding |
|
| Non-intestinal sequelae including eye pain or joint pain |
|