Active clinical trials for "Cryptosporidiosis"

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.

The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin alone. Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive patients as their immune systems weaken. It is caused by a parasite that invades the intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a fever. Antibiotics (paromomycin and azithromycin) are usually used to treat cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12. IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function. Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis.

The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.

This study evaluates the safety, tolerability, pharmacokinetics, and efficacy of treating Cryptosporidiosis in HIV positive patients with Clofazimine. Half of the HIV positive patients with Cryptosporidiosis enrolled will be treated with Clofazimine while the other half will be given placebo. An additional group of HIV positive patients without Cryptosporidium infection or diarrhea will be given Clofazimine to assess the differences in pharmacokinetics between HIV positive patients with and without Cryptosporidiosis and diarrhea.

There is no proven effective treatment for chronic diarrhea caused by the parasite Cryptosporidium in advanced AIDS. This trial will test the safety of interleukin-12 (IL-12) as part of a combination therapy for this parasite.

To determine the safety and effectiveness of intravenous spiramycin in patients with AIDS-related cryptosporidial diarrhea. Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin.

To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.

To determine the frequency of complete, marked, and partial clinical responses in patients with cryptosporidiosis treated with 6 weeks of NTZ versus 21 days of placebo. To determine the safety of NTZ in subjects with cryptosporidiosis. There is no proven therapy for cryptosporidiosis in persons with AIDS. Nitazoxanide appears to be a good candidate drug for further evaluation because of its effectiveness in preclinical models, the data from early clinical trials and its safety profile. Cooperation between clinical researchers and basic scientists in clinical trials of agents for HIV infection and its complications is a high priority for the ACTG, the NIAID, and the NIH. Thus, it is important to design a clinical trial of NTZ that includes cooperation with basic scientists.

Background: Burden: Cryptosporidiosis among the top 10 causes of diarrhea in the 1st year of life in low and middle-income countries (LMICs), with an estimated total of 48,000 annual deaths and accounting for 4.2 million disability-adjusted life years lost. Knowledge gap: The only approved drug for the treatment of diarrhea caused by Cryptosporidium infection is Nitazoxanide (NTZ) but NTZ has a higher failure rate in malnourished children. The lack of effective therapy for cryptosporidiosis remains an immense knowledge gap in the efforts to improve childhood health worldwide. Hypothesis: NTZ treatment failure in malnourished infants is due to a secondary immune deficiency that can be reversed by the appropriate therapeutic treatment. Lactobacillus reuteri DSM 17938 can have a potential immune modulating effect by altering gut microbiome promoting NTZ action. Objectives: Primary: • To develop new approaches to treat and prevent cryptosporidiosis Secondary: Determination of the treatment outcome of NTZ against cryptosporidiosis in Bangladeshi children. Determination of the change in effectiveness of NTZ treatment in conjunction with the administration of probiotics in malnourished Bangladeshi children with cryptosporidiosis Methods: This will be a prospectively conducted randomized pilot study with 2 arms in children in the Mirpur (Dhaka, Bangladesh) slum area, where cryptosporidium infected children will receive Nitazoxanide treatment with or without the probiotic, Lactobacillus reuteri DSM 17938. Outcome measures/variables: The significance of the work lies in the ability of the study to provide new approaches to treat and prevent Cryptosporidiosis. The goal of this work is to assess the efficacy of NTZ drug in a low socioeconomic Bangladeshi population and establish new supportive therapeutic measures to the already established treatment with NTZ against in cryptosporidiosis.

To examine the efficacy of cow's milk immune globulin in the treatment of diarrhea due to chronic intestinal cryptosporidiosis in patients with AIDS. The secondary end points of the study involve functional improvement which will be determined from nutritional and absorption studies.