Secondary analysis of effectivness of tinidazole-containing-quadruple eradication therapy in asymptomatic H. pylori infected children in El Paso

Helicobacter pylori infection is frequently acquired during childhood. This microorganism is known to cause gastritis, and duodenal ulcer in pediatric patients, however most children remain completely asymptomatic to the infection. Currently there is no consensus in favor of treatment of H. pylori infection in asymptomatic children. The firstline of treatment for this population is triple medication therapy including two antibacterial agents and one proton pump inhibitor for a 2 week duration course. Decreased eradication rate of less than 75% has been documented with the use of this first-line therapy but novel tinidazole-containing quadruple sequential therapies seem worth investigating. None of the previous studies on such therapy has been done in the United States of America. As part of an iron deficiency anemia study in asymptomatic H. pylori infected children of El Paso, Texas, we conducted a secondary data analysis of study data collected in this trial to assess the effectiveness of this tinidazole-containing sequential quadruple therapy compared to placebo on clearing the infection. Subjects were selected from a group of asymptomatic children identified through household visits to 11,365 randomly selected dwelling units. After obtaining parental consent and child assent a total of 1,821 children 3-10 years of age were screened and 235 were positive to a novel urine immunoglobulin class G antibodies test for H. pylori infection and confirmed as infected using a 13C urea breath test, using a hydrolysis urea rate >10 μg/min as cut-off value. Out of those, 119 study subjects had a complete physical exam and baseline blood work and were randomly allocated to four groups, two of which received active H. pylori eradication medication alone or in combination with iron, while the other two received iron only or placebo only. Follow up visits to their houses were done to assess compliance and occurrence of adverse events and at 45+ days post-treatment, a second urea breath test was performed to assess their infection status. The effectiveness was primarily assessed on intent to treat basis (i.e., according to their treatment allocation), and the proportion of those who cleared their infection using a cut-off value >10 μg/min of for urea hydrolysis rate, was the primary outcome. Also we conducted analysis on a per-protocol basis and according to the cytotoxin associated gene A product of the H. pylori infection status. Also we compared the rate of adverse events across the two arms. On intent-to-treat and per-protocol analyses, 44.3% and 52.9%, respectively, of the children receiving the novel quadruple sequential eradication cleared their infection compared to 12.2% and 15.4% in the arms receiving iron or placebo only, respectively. Such differences were statistically significant (p<0.001). The study medications were well accepted and safe. In conclusion, we found in this study population, of mostly asymptomatically H. pylori infected children, living in the US along the border with Mexico, that the quadruple sequential eradication therapy cleared the infection in only half of the children receiving this treatment. Research is needed to assess the antimicrobial susceptibility of the strains of H. pylori infecting this population to formulate more effective therapies. ^

Prevalence of Staphylococcus aureus colonization among high-risk HIV populations

Staphylococcus aureus is a common microorganism in humans, typically colonizing the nasopharynx, skin and other mucosal surfaces. It is among the most frequent causes of clinically-significant bacterial infections accounting for increased morbidity and mortality among individuals with HIV/AIDS. Evidence of higher colonization rates among high-risk HIV populations have been observed however, prevalence estimates have varied. Additionally, behavioral, biological, and/or environmental factors that may account for these high colonization rates are not understood. Previous literature on clinic-based surveys were subject to considerable biases. Additionally, representative samples of high-risk HIV populations were difficult to obtain due in part to an underrepresentation of individuals who may not regularly obtain health care. ^ The main objective of this project is to determine the prevalence of methicillin-sensitive S. aureus (MSSA) and methicillin-resistant (MRSA) nasal colonization in two populations: 1) men who have sex with men (MSM) and 2) injection drug users (IDU). Both of these populations are included in the third round of the National HIV Behavioral Surveillance System (NHBS) in Houston, Texas. ^ In the NHBS-MSM3 study, logistic regression was used to report odds ratios and 95% confidence intervals (CI). For the NHBS-IDU3 study, to account for the lack of independence between samples, the method of generalized estimating equations was utilized to report adjusted odds ratios and 95% CI. The NHBS-MSM3 study enrolled 202 participants with a MSSA colonization rate of 26.7% and MRSA rate of 3%. In the NHBS-IDU3 study, 18.4% were nasally colonized with MSSA and 5.7% were nasally colonized with MRSA. Among the NHBS-MSM3 population, high-risk sexual practices were associated with colonization. For the NHBS-IDU3 population, age, marital status, employment status, and the presence of scabs, were associated with colonization status when controlling for size of recruitment network. In multivariate GEE analyses, the use of antiretroviral medications and age remained significantly associated with S. aureus nasal colonization when controlling for size of recruitment network and gender. In both studies, a significantly higher than expected S. aureus and MRSA colonization rate was observed as compared to colonization rates described for the general population. However, these estimates were moderate in comparison to reported clinic-based MSM and IDU S. aureus colonization findings. This study validates substantial prevalence differences and biases that may exist with data collected from clinic-based MSM and IDU. The prevalence of MSSA and MRSA nasal colonization did not differ significantly with respect to HIV status among NHBS-MSM3/NHBS-IDU3 participants. Continued examination on the effects of S. aureus colonization and infection should be examined longitudinally to confirm additional community-based determinants in populations that are disproportionately affected.^