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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05208970
Other study ID # Soh-Med-22-01-12
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date January 2025

Study information

Verified date April 2024
Source Sohag University
Contact Salwa GA Omran, assistant lecturer
Phone 01011154173
Email salwa.omran@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cryptosporidium species are increasingly recognized as important enteric pathogens that infect a broad range of hosts including human, domestic and wild animals worldwide, causing asymptomatic or mild-to-severe gastrointestinal disease in their host species. There are 38 species of Cryptosporidium that have been described, going from amphibian parasites to mammals ones, with over 40 genotypes infecting mammals, although Cryptosporidium parvum and Cryptosporidium hominis are the two species predominantly reported in human infections. In Cairo and Sharkyia governorates in Egypt, Cryptosporidium is a common intestinal parasite among children, especially in diarrheic, preschool-aged children, with a predominance of C. hominis indicates anthroponotic rather than zoonotic transmission. Also in the sohag governorate, Cryptosporidium infection is a common intestinal parasite, as in the last five years its prevalence about 35% but there is no study clarify predominant genotype of Cryptosporidium in sohag.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Age: any age 2. Sex: male -female 3. Residence: rural-urban 4. Animal contact. 5. Immune status: immunocompetent - immunocompromised 6. Clinical manifestations: diarrhea -abdominal pain- fever- vomiting. Exclusion Criteria: - patients taking treatment for cryptosporidiosis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Faculty of Medicine, Sohag University Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Benamrouz S, Guyot K, Gazzola S, Mouray A, Chassat T, Delaire B, Chabe M, Gosset P, Viscogliosi E, Dei-Cas E, Creusy C, Conseil V, Certad G. Cryptosporidium parvum infection in SCID mice infected with only one oocyst: qPCR assessment of parasite replication in tissues and development of digestive cancer. PLoS One. 2012;7(12):e51232. doi: 10.1371/journal.pone.0051232. Epub 2012 Dec 13. — View Citation

Kvac M, Havrdova N, Hlaskova L, Dankova T, Kandera J, Jezkova J, Vitovec J, Sak B, Ortega Y, Xiao L, Modry D, Chelladurai JR, Prantlova V, McEvoy J. Cryptosporidium proliferans n. sp. (Apicomplexa: Cryptosporidiidae): Molecular and Biological Evidence of Cryptic Species within Gastric Cryptosporidium of Mammals. PLoS One. 2016 Jan 15;11(1):e0147090. doi: 10.1371/journal.pone.0147090. eCollection 2016. — View Citation

Mohammad SM, Ali MS, Abdel-Rahman SA, Moustafa RA, Sarhan MH. Genotyping of Cryptosporidium species in children suffering from diarrhea in Sharkyia Governorate, Egypt. J Infect Dev Ctries. 2021 Oct 31;15(10):1539-1546. doi: 10.3855/jidc.14367. — View Citation

Ryan U, Zahedi A, Paparini A. Cryptosporidium in humans and animals-a one health approach to prophylaxis. Parasite Immunol. 2016 Sep;38(9):535-47. doi: 10.1111/pim.12350. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary estimate the prevalence and clarify the species and genotypes/subtypes of Cryptosporidium spp. in sohag. 24 weeks
Secondary clarify the relationship of them in a phylogenetic context and to provide additional information on the molecular epidemiology of this parasite in our locality 24 weeks
Secondary clarify the predominant clinical manifestation of each genotypes/subtypes of Cryptosporidium spp 24 weeks
Secondary clarify the relationship between genotypes/subtypes of Cryptosporidium spp. and different risk factors. 24 weeks
See also
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Completed NCT00000771 - A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 Phase 2
Completed NCT00002062 - Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients N/A
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Completed NCT00002328 - Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs N/A
Completed NCT00001018 - A Study of Letrazuril in the Treatment of AIDS-Related Diarrhea Phase 1
Completed NCT00002027 - Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433) N/A