Health Condition 1: A071- Giardiasis [lambliasis]
Conditions
Interventions
Intervention1: Nitazoxanide 500 mg Tablets and Placebo: The study will consist of multicentric and eligible Subjects as per randomization are required to receive the generic Nitazoxanide tablets 500 m
Sponsors
Rising Pharmaceuticals Inc
AXIS Clinicals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Infection with Giardia lamblia in immunocompetent male or female patients aged more than or equal to 12 years Patients with diarrhea more than or equal 3 unformed stools per day with one or more enteric symptoms such as abdominal pain or cramps nausea vomiting tenesmus or malabsorption Giardia lamblia cysts detected in a stool specimen obtained during screening Willing to give their patient or legal guardian written informed consent or written informed assent to participate in the study Patients should be stable on their disease for the participation in the study as per the Principal Investigators PI discretion
Exclusion criteria
Exclusion criteria: An additional intestinal pathogen that might contribute to the presenting symptoms eg pathogenic bacteria such as Salmonella Shigella Entamoeba histolytica Cryptosporidium parvum Administration of drugs known to affect intestinal motility or diarrhea within 7 days of enrollment Stool colony count of more than 10000 Colony forming units CFU per ml for diarrhea causing pathogens Use within 2 weeks of enrollment of any drug or therapy with antiprotozoal activity including 5 nitroimidazoles such as metronidazole tinidazole ornidazole secnidazole paromomycin nitazoxanide azithromycin hydroxyquinoline derivatives acetamide analogues such as diloxanide paromomycin and nitazoxanide Trimethoprim sulfamethoxazole may be used within 2 weeks of enrollment but may not be used concomitantly during therapy Patients known or suspected of having HIV/AIDS Patients with compromised renal or hepatic function Patients with chronic gastrointestinal illness such as IBS or IBD etc Patients with malnutrition defined as a BMI less than 18.5 kg per m2 in adults and BMI =12 years of age Concomitant use of warfarin antimicrobial drugs and drugs with antiprotozoan activity other than the study drugs Females who are pregnant suspected of being pregnant or breast feeding urine pregnancy tests are required for all women of childbearing potential or who are two years or less post-menopausal Serious systemic disorders incompatible with the study as per PIs discretion History of hypersensitivity to Nitazoxanide or other sulphur containing drugs like penicillins sulphonamides etc Patients in whom the possibility of receiving a placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patients illness according to the Investigators judgment Patients with known immune deficiencies eg cancer chemotherapy patients patients with hypogammaglobulinemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint used to determine efficacy is the clinical response, resolution of clinical symptoms associated with giardiasis the proportion of patients with a well clinical response evaluated on Days 7 plus 1 and 9 plus 1 will be the endpoint compared between treatments A clinical response of well is defined as either No symptoms no watery stool and no more than 2 soft stools with no hematochezia within the past 24 hours No symptoms and no unformed stools within the past 48 hoursTimepoint: Resolution of clinical symptoms associated with giardiasis the proportion of patients with a well clinical response evaluated on Days 7 plus 1 and 9 plus 1 will be the endpoint compared between treatments A clinical response of well is defined as either No symptoms no watery stool and no more than 2 soft stools with no hematochezia within the past 24 hours No symptoms and no unformed stools within the past 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| A parasitological response is defined as no cysts or trophozoites in either of the two stool samples collected between 4 to 7 days after completion of therapy Visits 3 and 4 that is on Days 7 plus 1 and 9 plus 1Timepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Subhra Lahiri
AXIS Clinicals Ltd
Outcome results
None listed