Auranofin PK Following Oral Dose Administration
AmoebiasisPhase I, open-label study in 15 healthy adult subjects receive 6 mg of auranofin orally once every 24 hours for 7days. Blood samples will be taken for 17 weeks following the last dose of auranofin for determination of terminal phase pharmacokinetic parameters. Stool samples will also be obtained for the measurement of gold.
Study of Nitazoxanide in the Treatment of Amebiasis in Children
AmebiasisThe purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by Entamoeba histolytica in children.
Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole...
HelminthiasisAmoebiasisThe purpose of this study is to assess the efficacy and safety of the combination of mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in Mexican population.
Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents
AmebiasisThe purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.
Auranofin for Giardia Protozoa
Amoebic DysenteryGiardiasisThis is a phase IIa, randomized, placebo-controlled, single-blinded superiority treatment study in males and non-pregnant females, 18 to 65 years of age who are in good health. This study is designed to compare placebo to once daily doses of 6mg auranofin for adults with amebiasis or giardiasis. A sample size of 68 subjects enrolled with amebiasis (34 per arm) and 68 with giardiasis (34 per arm); Power based on 60 subjects with amebiasis and 60 with giardiasis completing the study.Eligible subjects will be randomly assigned to a treatment group with auranofin (6 mg orally once daily for 5 days for giardiasis or 7 days for amebiasis) compared to a placebo group receiving similar but not identical placebo capsules. Projected duration of subject participation will be approximately 30 days of face to face visits, including the pre-enrollment screening period of up to 4 days. It is anticipated that it will take approximately 3.5 years to finish the study. Primary objectives are: 1) to compare the proportion of subjects with stools positive by rapid Enzyme Immunoassay (EIA) and positive antigen detection EIA for E. histolytica at enrollment with resolution of diarrhea (less than 3 loose stools/24 hrs) by Day 7 for E. histolytica infections. 2) to compare the proportion of subjects with stools positive by rapid EIA and positive antigen detection EIA for Giardia at enrollment with resolution of diarrhea (less than 3 loose stools/24 hrs) by Day 5 for Giardia infections.
Parasitic Infections of the Gastrointestinal Tract
AmebiasisCryptosporidiosis4 moreThis protocol offers diagnosis and standard medical treatment for various parasitic gastrointestinal infections. Gastrointestinal parasites are either worms (helminths) or one-celled animals called protozoans which live in the human intestines. Often, parasitic infections do not cause illness. In these cases, drug treatment is not indicated, because treatment can have adverse side effects. Patients will be examined for their immune responses, correlation between the number of parasites and disease, and other studies. Individuals with known or suspected parasitic diseases of the gastrointestinal tract, including amebiasis, giardiasis, hookworm, strongyloidiasis, trichuriasis, pinworm, tapeworm, trichinosis, clonorchis, opisthorchis, coccidiosis, paragonimiasis, and echinococcus may be eligible for this study. Patient evaluations may include blood and urine tests, stool examination, X-rays, ultrasound studies and, uncommonly, duodenal aspiration for examination of fluid from the duodenum (first part of the small intestine). Other tests may be required, depending on the parasite and disease. Direct examination of the tissues of the intestines may be required to rule out certain infections. Research procedures include collection of stool, blood and duodenal fluid when the diagnosis has been established and these procedures are not required for medical care. Patients with strongyloidiasis may also be given a diagnostic skin test similar to skin tests for tuberculosis and allergies. Research procedures on children will be limited to collection of stool, urine and blood. No more than 7 milliliters (1 1/2 teaspoons) per kilogram (2.2 pounds) body weight of blood will be collected in children over a 6-week period. In adults no more than 30 tablespoons of blood will be collected in a 6-week period. Parasites may fail to respond to treatment. In these cases, it may be necessary to grow the parasite in the laboratory in order to test treatments in the test tube. Patients who do not respond to standard medications and dosing may need different doses of drugs or drugs or combinations of drugs used in the United States for other medical problems. If these medications or doses are used, patients will be informed of their possible side effects.
Anaemetro I.V. Infusion 500mg Drug Use Investigation
Anaerobic InfectionInfectious Enterocolitis1 moreSecondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice
Ameparomo Capsules 250 mg Drug Use Investigation
Intestinal AmebiasisThis Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.
Primary Cecal Pathologies Presenting as Acute Abdomen
Acute AbdomenEmergency Surgery4 moreBackground: The importance of cecal pathologies lie in the fact that being the first part of large intestine, any disease involving the cecum affects overall functioning of the large bowel. Primary cecal pathologies presenting as acute abdomen have not been described in any previous study in terms of presentation, management and outcome. Objectives: The objective of this study was to identify the reported causes of primary cecal pathologies presenting as acute abdomen and the various causes presenting in Indian setting, to discuss morbidity and mortality associated with cecal pathologies and to critically analyse the various management modalities employed in emergency setting.
Field Studies of Amebiasis in Bangladesh
AmebiasisCryptosporidiumThe purpose of this study will be to investigate the incidence of both Amebiasis and cryptosporidiosis in Bangladeshi children and examine genetic variation in innate and adaptive immunity with respect to these infections. Novel diagnostics to these infections will also be investigated.