RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study.

BACKGROUND: Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. It induces preterm births and low birth weight (LBW) deliveries, long-term neurodevelopmental sequelae, and an increased risk of earlier onset of postnatal iron deficiency. Anemia rates are among the highest in South Asia, and India's National Family Health Survey (NFHS-5) for 2019-2021 indicated that over half of pregnant women, and more than 65% of children, in the country are classified as anemic (Sciences IIfP, National Family Health Survey-5, 2019-21, India Fact Sheet). In 2021, the parent RAPIDIRON Trial (Derman et al., Trials 22:649, 2021) was initiated in two states in India, with the goal of assessing whether a dose of intravenous (IV) iron given to anemic women during early pregnancy results in a greater proportion of participants with normal hemoglobin concentrations in the third trimester and a lower proportion of participants with LBW deliveries compared to oral iron. As a follow-up to the RAPIDIRON Trial, the RAPIDIRON-KIDS Study will follow the offspring of previously randomized mothers to assess, neurobehavioral, hematological, and health outcomes. METHODS: This prospective observational cohort study will follow a subset of participants previously randomized as part of the RAPIDIRON Trial and their newborns. Study visits occur at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months and include blood sample collection with both maternal and infant participants and specific neurobehavioral assessments conducted with the infants (depending on the study visit). The primary outcomes of interest are (1) infant iron status as indicated by both hemoglobin and ferritin (a) at birth and (b) at 4 months of age and (2) the developmental quotient (DQ) for the cognitive domain of the Bayley Scales of Infant Development Version IV (BSID-IV) at 24 months of age. DISCUSSION: This RAPIDIRON-KIDS Study builds upon its parent RAPIDIRON Trial by following a subset of the previously randomized participants and their offspring through the first 3 years of life to assess neurodevelopmental and neurobehavioral (infants, children), hematological, and health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05504863 , Registered on 17 August 2022. Clinical Trials Registry - India CTRI/2022/05/042933 . Registered on 31 May 2022.

Uptake of universal drug susceptibility testing among people with TB in a south Indian district: How are we faring?

BACKGROUND: India implements universal drug susceptibility testing (UDST) using rapid genotypic tests (cartridge-based nucleic acid amplification test CBNAAT - and line probe assay - LPA). to bridge the gap of diagnosis of multidrug/rifampicin-resistant TB. There is limited evidence assessing the implementation of UDST in India. We assessed the implementation among people with pulmonary TB notified from public facilities in October 2019 from Raichur (Karnataka), India. METHODS: A cohort study involving secondary data in routine programme settings was conducted. All people with TB underwent a rapid genotypic DST for rifampicin resistance followed by first line-LPA (FL-LPA) if sensitive and second line-LPA (SL-LPA) if resistant. RESULTS: Of 217 people, 15.7% (n=34) did not undergo rapid genotypic DST. Of 135 who were rifampicin-sensitive detected on CBNAAT, 68.1% (n=92) underwent FL-LPA, and out of the six rifampicin-resistant cases, 66.7% (n=4) underwent SL-LPA. Overall, 65.4% (142/217) completed the UDST algorithm. Children (aged <15 y) and people with bacteriological non-confirmation on microscopy were less likely to undergo rapid genotypic DST. Of 183 patients who underwent both rapid genotypic DST and sputum smear microscopy, 150 were bacteriologically confirmed and, of them, 9 (6%) were 'rapid DST-negative'. CONCLUSION: We found gaps at various steps. There were a significant number of 'rapid DST-negative, smear-positive' patients.

Isolation and Antibiotic Susceptibility Pattern of Escherichia coli from Urinary Tract Infections in a Tertiary Care Hospital of North Eastern Karnataka.

INTRODUCTION: Clinical management of the urinary tract infections (UTI) is influenced by the antimicrobial vulnerability patterns. OBJECTIVE: The study aimed to analyse the resistance pattern of the Escherichia coli (E. coli) causing UTI in patients over a period of 4 years from 2012 to 2015. MATERIALS AND METHODS: 1000 samples from patients suspected of having urinary tract infections were collected and processed for culture and antimicrobial drug susceptibility as per the routine microbiological techniques. RESULTS: Of the total 1000 samples, 395 cases were culture-positive for E. coli. These isolates were tested for antibiotic susceptibility by disk diffusion method. Of the total 395 E. coli isolates, 170 (43%) were multi drug resistant (MDR). The isolates showed high level of resistance to Ampicillin (82.53%), Cefuroxime (72.41%), Amoxycillin-clavulinic acid (71.90%), Ceftriaxone (66.58%), Ciprofloxacin (65.82%) and Cefepime (57.47%). The isolates were sensitive to Imipenem (96.71%), Nitrfurantion (92.41%), Amikacin (90.89%), Chloramphenicol (85.82%), Piperacillin-tazobactum (80.76%), Gentamicin (59.24%), Azetreonam (54.43%) and Norfloxacin (53.67%). CONCLUSION: We conclude that a significant number of the urinary tract infections in our study subjects were caused by multiple drug resistant E. coli. The sensitivity pattern showed a continued decline from 2012 to 2015, with Imipenem being currently the most effective antibiotic.

Seroepidemiological Survey of Chikungunya in and Around the Regions of Bijapur (Vijayapura - North Karnataka).

BACKGROUND: Chikungunya is a debilitating, non-fatal, mosquito borne viral fever caused by Chikungunya virus (CHIVA). The disease is transmitted to humans by the bite of Aedes aegypti and Aedes albopictus mosquitoes. Severe outbreaks of Chikungunya have been reported in several countries of Africa and Asia. Chikungunya fever is characterized by fever with sudden onset, arthralgia, rash, headache and myalgia. However, arthralgia is painful and long-lasting, affecting primarily the peripheral joints. OBJECTIVES: To find out the prevalence of Chikungunya fever in and around the regions of Bijapur district. MATERIALS AND METHODS: The study was conducted from April 2011 to December 2014. Five hundred serum samples were collected from cases with pyrexia and arthralgia. Serum samples were tested for Chikungunya antibodies by Chikungunya IgM ELISA. RESULTS AND CONCLUSION: Out of 500 samples 33 samples were confirmed positive for Chikungunya IgM antibodies. The prevalence rate of Chikungunya was 6.6% with maximum number of cases in the year 2013 (8.5%) and age group 15 to 40 (8.3%). Females (6.9%) were more affected than males. Thus, continuous sero-epidomological surveillance is needed for the control of Chikungunya fever.

Estimation and comparison of salivary immunoglobulin A levels in tobacco chewers, tobacco smokers and normal subjects.

AIMS: To estimate the salivary immunoglobulin A (IgA) levels in tobacco chewers, tobacco smokers and normal subjects and to compare the salivary IgA levels among tobacco chewers and tobacco smokers. METHODS: The study group consisted of 80 subjects (tobacco users), 40 tobacco chewers and 40 tobacco smokers. Unstimulated whole saliva was collected from all tobacco users and 40 healthy age- and gender-matched non-tobacco users as control group. The study and control groups were divided into four subgroups based on age range. Salivary IgA levels were estimated by single radial immunodiffusion assay (SRID). All data were analysed using statistical software and to compare the results in three groups, single-factor analysis of variance was applied. RESULTS: The mean salivary IgA level in control group was 16.76 ± 1.37 mg/dl (SD); in tobacco chewers it was 7.89 ± 0.61 mg/dl (SD) and in tobacco smokers it was 6.55 ± 0.99 mg/dl (SD). The salivary IgA levels were decreased in tobacco chewers and tobacco smokers compared with the controls. Among the tobacco users, tobacco smokers had much reduced salivary IgA levels compared to tobacco chewers. All of these results were highly significant (P<0.001). CONCLUSIONS: The present study showed that tobacco chewers and tobacco smokers had decreased salivary IgA levels and among tobacco users, tobacco smokers had much reduced salivary IgA levels compared to tobacco chewers in unstimulated whole saliva.

Comparison of the Lowenstein-Jensen Medium, the Middlebrook 7H10 Medium and MB/BacT for the Isolation of Mycobacterium Tuberculosis (MTB) from Clinical Specimens.

INTRODUCTION: Tuberculosis (TB) is the most common cause of death due to a single infectious agent worldwide in adults. India alone accounts for 30% of the global tuberculosis burden. There is a need for a method of cultivation of mycobacteria that is reliable and economical and has a short turnaround time. OBJECTIVE: The present study was attempted to assess the feasibility of using MB BACT and Middlebrook 7h10(MB7H10) as primary isolation media for mycobacteria. They were compared with the LJ medium, which was the gold standard. MATERIALS AND METHODS: Various clinical specimens from a total of 236 clinically suspected cases of TB were studied. All the samples were decontaminated by using the modified Petroff's method. Each sample was subjected to ZN staining and it was simultaneously inoculated onto the LJ medium, the MB7H10 medium and MB BACT. The growth from the cultures were confirmed by ZN staining and they were speciated by using biochemical reactions. RESULTS: Out of the 236 samples which were screened, 116 isolates were obtained. All the 116 were isolated from MB BACT, 82 were isolated from the LJ medium and 62 were isolated from MB7H10. 82 isolates were obtained from MB BACT and the LJ medium, 62 were obtained from MB7H10 and MB BACT, 58 were isolated from LJ and MB7H10 and 58 were isolated from LJ medium, MB7H10 and MB bact. Neither the L J medium nor the Middlebrook 7h 10 medium could isolate mycobacteria exclusively. It showed that the combination of media did not prove to be superior over the use of MB BACT alone. The average isolation time of L J, the MB7H10 medium and MB BACT was 30.81 days, 31.06 days and 18.70 days. INTERPRETATION AND CONCLUSION: MB BACT is a better medium as compared to the L J medium and the MB7H10 medium, both in terms of the number of isolates and the isolation rate. The MB BACT method proved to be a very speedy method and it could isolate mycobacteria 7-10 days earlier as compared to the L J medium and the Middlebrook 7 H10 medium.

Sequence of oral manifestations in rhino-maxillary mucormycosis.

Mucormycosis, caused by saprophytic fungi of the order Mucorales of the class Zygomycetes, is a rare opportunistic fungal infection, which has a rapidly progressive and fulminant course with fatal outcome. These fungi are ubiquitous, found in soil, bread molds, decaying fruits and vegetables. The most common form of mucormycosis is rhinocerebral and is usually seen in uncontrolled diabetes mellitus or in immunocompromised patients. This fungus invades the arteries, leading to thrombosis that subsequently causes necrosis of hard and soft tissues. We report a case of palatal perforation by rhino-maxillary mucormycosis in an immunocompromised patient. The aim of this article is to draw attention to the clinical presentation and pathogenesis of mucormycosis and to emphasize the need for high degree of suspicion in its diagnosis and management.

Anti-microbial resistance profile of Citrobacter species in a tertiary care hospital of Southern India.

BACKGROUND: Recently, the isolation of this pathogen in hospital settings is increasing and multidrug-resistant strains are emerging; these strains present a challenge for clinician and the clinical microbiologist because of their increased occurrence in nosocomial infection. The current study was done to find out the antibiotic sensitivity pattern of Citrobacter species from various clinical specimens. MATERIALS AND METHODS: Samples were collected from patients in accordance with standard protocols. Citrobacter species were identified by conventional biochemical tests. Antibiotic susceptibility of the isolates was done by disc diffusion method according to National Committee for Clinical Laboratory Standards (NCCLS) recommendations. RESULTS: Out of 563 isolates of Citrobacter, majority were from pus (48.1%), followed by urine (24.3%), sputum (20.3%), body fluids (05.2%), blood (02.1%). C. koseri was the predominant species [391 (70%)] isolated. Infection was nosocomialy acquired in 493 (87.4%) patients. The mean age was 39.5 years. Anti-biograms of Citrobacter isolates revealed that effective agent against Citrobacter isolates was imipenem (91.8% sensitive), followed by piperacillin/tazobactam (58.3%) and amikacin (53.4%). CONCLUSION: Citrobacter isolates resistant to multiple anti-microbial agents have emerged, including strains resistant to imipenem, making it an emerging nosocomial pathogen. Therefore, the results of this study suggest that surveillance of anti-microbial resistance in Citrobacter is necessary. Antibiotic policy should be formulated in the hospital. Depending on the antibiotic sensitivity pattern of the Citrobacter isolates, antibiotics should be used, and proper infection control measures should be strictly followed to prevent spread of this pathogen.