Transmission and the Respiratory Tract in Cryptosporidiosis

NCT00507871 | Completed

• 1 other identifier: 06-0033
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

Cryptosporidium is an intestinal parasite that causes diarrhea in children and adults. In addition to infection of the stomach, this parasite can infect the respiratory system causing a cough and/or problems breathing. This study will enroll 480 children between the ages of 9 and 36 months who come to Mulago Hospital for treatment of diarrhea. Researchers believe a large number of children with diarrhea and cough will have the parasite present in their sputum (mucus coughed up). Researchers also believe that children who have respiratory tract cryptosporidiosis may have a cough, increased number of breaths per minute, and/or a lower oxygen level. Blood, stool, saliva, and sputum samples will be collected from all children in the study and tested for Cryptosporidium. Children too young to provide a sputum sample will have a tube placed to collect a mucus sample from the lungs. Study participation may be as short as 4 hours or as long as 2 days depending on each child's health.

Conditions

Cryptosporidiosis

Keywords

cryptosporidiosis, Cryptosporidium, Uganda, diarrhea

Eligibility Criteria

• Age: 9 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children attending the Acute Care Unit at Mulago Hospital, Kampala, Uganda

You may qualify if:

• Male and female children aged 9-36 months at the time of enrollment
• Presence of acute or persistent diarrhea (diarrhea defined as 3 or more loose stool in the previous 24 hours AND not considered normal for that child if the child is exclusively breast fed OR any number of bloody stools in the previous 24 hours; less than or equal to 14 days duration for acute diarrhea; \>14 days duration for persistent diarrhea)
• Child's parent/guardian speaks English or Luganda
• Parent/guardian provides full and free informed consent for child to participate in study

You may not qualify if:

• Unknown age
• Known cardiac, CNS, metabolic or endocrine disorders
• Moribund children
• Children with recent history of choking or sudden onset of symptoms with suspected foreign body inhalation

Sponsors & Collaborators

• Tufts University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Makerere University Medical School

Kampala, Uganda

Location

Related Publications (1)

• Mor SM, Tumwine JK, Ndeezi G, Srinivasan MG, Kaddu-Mulindwa DH, Tzipori S, Griffiths JK. Respiratory cryptosporidiosis in HIV-seronegative children in Uganda: potential for respiratory transmission. Clin Infect Dis. 2010 May 15;50(10):1366-72. doi: 10.1086/652140.

  PMID: 20377408 DERIVED

MeSH Terms

Conditions

Cryptosporidiosis; Diarrhea

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Animal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrery K Griffiths, MD

  Tufts Universtiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 3, 2009

Record last verified: 2007-09

Locations

UG (1)