Increased risk of acquisition and transmission of ESBL-producing Enterobacteriaceae in malnourished children exposed to amoxicillin

2019 ◽  
Vol 75 (3) ◽  
pp. 709-717 ◽  
Author(s):  
Naouale Maataoui ◽  
Céline Langendorf ◽  
Fatou Berthe ◽  
Jumamurat R Bayjanov ◽  
Willem van Schaik ◽  
...  
Keyword(s):  
Placebo Group ◽  
Severe Acute Malnutrition ◽  
Controlled Trial ◽  
Acute Malnutrition ◽  
Double Blind ◽  
Adjusted Risk ◽  
Malnourished Children ◽  
Nutritional Recovery ◽  
Adjusted Risk Ratio ◽  
Increased Risk

Abstract Objectives Routine amoxicillin for children with uncomplicated severe acute malnutrition raises concerns of increasing antibiotic resistance. We performed an ancillary study nested within a double-blind, placebo-controlled trial in Niger testing the role of routine 7 day amoxicillin therapy in nutritional recovery of children 6 to 59 months of age with uncomplicated severe acute malnutrition. Methods We screened 472 children for rectal carriage of ESBL-producing Enterobacteriaceae (ESBL-E) as well as their household siblings under 5 years old, at baseline and Week 1 (W1) and Week 4 (W4) after start of therapy, and characterized strains by WGS. ClinicalTrials.gov: NCT01613547. Results Carriage in index children at baseline was similar in the amoxicillin and the placebo groups (33.8% versus 27.9%, P = 0.17). However, acquisition of ESBL-E in index children at W1 was higher in the amoxicillin group than in the placebo group (53.7% versus 32.2%, adjusted risk ratio = 2.29, P = 0.001). Among 209 index and sibling households possibly exposed to ESBL-E transmission, 16 (7.7%) had paired strains differing by ≤10 SNPs, suggesting a high probability of transmission. This was more frequent in households from the amoxicillin group than from the placebo group [11.5% (12/104) versus 3.8% (4/105), P = 0.04]. Conclusions Among children exposed to amoxicillin, ESBL-E colonization was more frequent and the risk of transmission to siblings higher. Routine amoxicillin should be carefully balanced with the risks associated with ESBL-E colonization.

scholarly journals Neurological Development and Iron Supplementation in Healthy Late-Preterm Neonates: A Randomized Double-Blind Controlled Trial

2021 ◽  
Author(s):  
Rita Luciano ◽  
Domenico Marco Romeo ◽  
Giuseppina Mancini ◽  
Serena Sivo ◽  
Carolina Dolci ◽  
...  
Keyword(s):  
Placebo Group ◽  
Iron Supplementation ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Neurological Development ◽  
Double Blind ◽  
Neurological Outcomes ◽  
Increased Risk ◽  
The Mean

Abstract ObjectiveLate-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelaeand iron deficiency. Aim of the study is to assess the positive effect of iron supplementation on neurological development in healthy LPT.DesignWe designed a perspective, randomized placebo-controlled double-blind trial. The newborns were randomized in two groups: thirty-three patients received martial prophylaxis, thirty-three placebo. Every patient was assessed using the Griffith Mental Development Scales (GMDS)-II edition at 12 months of post-conceptional age.SettingThe study was performed at the Neonatology Unit of Fondazione Policlinico Gemelli IRCCS.PatientsSixty-six healthy LPT infants born between 340⁄7 and 366⁄7 weeks of Gestational Age were enrolled in the study.InterventionsOne group received martial prophylaxis from the third week of life to six months of post-conceptional age (2 mg/kg/day of iron pidolate), the other received placebo.Main outcome measuresFifty-two of the enrolled infants were assessed using the GMDS at 12-month of post-conceptional age. Statistical analysis of the mean scores of the Griffith subscales was performed.ResultsThere was a difference in the mean Developmental Quotient (DQ) (p<0.01) between the two groups: Iron Group mean DQ 121.45+10.53 vs Placebo Group mean DQ 113.25+9.70. Moreover, mean scores of the Griffith subscales A, B and D showed significant differences between the two Groups (scale A p<0.05, scale B p<0.02, scale D p<0.01 respectively).ConclusionsOur data show that newborns who received iron supplementation during the first six months of life achieved significantly better neurological outcomes at GMDS than Placebo group.

scholarly journals Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Kieran S. O’Brien ◽  
Ali Sié ◽  
Clarisse Dah ◽  
Millogo Ourohire ◽  
Ahmed M. Arzika ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Severe Acute Malnutrition ◽  
Controlled Trial ◽  
Acute Malnutrition ◽  
World Health ◽  
Randomized Controlled ◽  
Nutritional Recovery ◽  
Routine Administration ◽  
Pilot Randomized Controlled Trial

Abstract Background Given the high risk of infectious mortality among children with severe acute malnutrition (SAM), the World Health Organization recommends routine administration of a broad-spectrum antibiotic like amoxicillin as part of the management of uncomplicated SAM. However, evidence for the efficacy of amoxicillin to improve nutritional recovery or reduce mortality has been mixed. With a long half-life and evidence of efficacy to reduce mortality in high-risk populations, azithromycin is a potential alternative to amoxicillin in the management of SAM. In this pilot study, we aim to compare the efficacy of azithromycin to amoxicillin to improve nutritional outcomes in children with uncomplicated SAM. Methods This pilot randomized controlled trial will enroll 300 children with uncomplicated SAM from 6 Centre de Santé et de Promotion Sociale in the Boromo health district in Burkina Faso. Eligible children are randomized to receive a single directly observed dose of oral azithromycin or a 7-day course of oral amoxicillin in addition to the standard package of care for uncomplicated SAM. Enrolled children are followed weekly until nutritional recovery, and all children return for a final study visit at 8 weeks after enrollment. Anthropometric indicators, vital status, and clinical outcomes are monitored at each visit and compared by arm. Primary feasibility outcomes include enrollment potential, refusals, loss to follow-up, and completeness of data collection. The primary clinical outcome is weight gain (g/kg/day) over the 8-week study period. Discussion This pilot trial will establish the feasibility of conducting a full-scale randomized controlled trial to evaluate alternative antibiotics in this setting and provide preliminary evidence for the efficacy of azithromycin compared to amoxicillin to improve outcomes for children with SAM. Trial registration This trial was first registered on clinicaltrials.gov on 26 June 2018 (NCT03568643).

Community-Based Management of Acute Malnutrition for Infants Under 6 Months of Age Is Safe and Effective: Analysis of Operational Data

2021 ◽  
pp. 1-27
Author(s):  
Maeve M. Woeltje ◽  
Anastasia B. Evanoff ◽  
Beth A. Helmink ◽  
Diana L. Culbertson ◽  
Kenneth M. Maleta ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Severe Acute Malnutrition ◽  
Acute Malnutrition ◽  
Community Based ◽  
Malnourished Children ◽  
Nutritional Recovery ◽  
Economic Barriers ◽  
Moderate Acute Malnutrition ◽  
Supplementary Foods ◽  
Operational Data

Abstract Objective: To assess the effectiveness of outpatient management with ready-to-use and supplementary foods for infants under 6 months (u6m) of age who were unable to be treated as inpatients due to social and economic barriers. Design: Review of operational acute malnutrition treatment records. Setting: 21 outpatient therapeutic feeding clinics in rural Malawi. Participants: Infants u6m with acute malnutrition treated as outpatients because of barriers to inpatient treatment. The comparison group consisted of acutely malnourished children 6-9 months of age who were being treated at the same time in the same location in the context of two different randomized clinical trials. Results: A total of 323 infants u6m were treated for acute malnutrition (130 severe and 193 moderate). A total of 357 infants 6-9 months old with acute malnutrition (74 severe and 283 moderate) were included as contemporaneous controls. Among infants u6m with severe acute malnutrition, 98 (75.4%) achieved nutritional recovery; in comparison, 56 (75.7%) of those with SAM 6-9 months old recovered. Among infants u6m with moderate acute malnutrition, 157 (81.3%) recovered; in comparison 241 (85.2%) of those aged 6-9 months recovered. Conclusions: In a rural Malawian population of infants u6m who had generally already stopped exclusive breastfeeding and were now acutely malnourished, treatment with therapeutic or supplementary foods under the community management of acute malnutrition model was safe and effective. In settings where social and financial factors make hospital admission challenging, consideration should be given to lowering the recommended age of ready-to-use therapeutic and supplementary foods to infants u6m.

scholarly journals Impact of prebiotic (Lacto-N-neotetraose) and probiotic (B. infantis EVC001) supplementation on gut inflammation and fecal pH in young infants suffering from severe acute malnutrition: findings from a randomized controlled trial

2020 ◽  
Author(s):  
Parag Palit ◽  
Sharika Nuzhat ◽  
Md Amran Gazi ◽  
Md Ridwan Islam ◽  
Mustafa Mahfuz ◽  
...  
Keyword(s):  
Placebo Group ◽  
Severe Acute Malnutrition ◽  
Controlled Trial ◽  
Acute Malnutrition ◽  
Gut Health ◽  
Gut Inflammation ◽  
Time Points ◽  
Young Infants ◽  
Fecal Ph ◽  
Multivariate Quantile

Abstract BackgroundSevere acute malnutrition (SAM) is associated with high levels of gamma Proteobacteria chronic gut inflammation and poor gut health. In this study, we aimed to assess the effects of probiotic and/or prebiotic supplementation on gut inflammation and fecal pH in young infants with SAM.MethodsThis study was a single-blind RCT where infants aged between 2 and 6 months were randomized to receive either: probiotic (B. infantis EVC001), synbiotic (prebiotic, Lacto-N-neotetraose [LNnT] plus probiotic [B. infantis EVC001]), or placebo (Lactose) for 28 days followed by 28 days of post-supplementation follow up. Stool samples were collected at baseline and at day 10, day 28 and day 56. Fecal myeloperoxidase (MPO), as an indicator of gut inflammation and fecal pH were measured and the change in the levels of these biochemical parameters between the sample collection time points were calculated and denoted as ∆MPO and ∆pH. Kruskal-Wallis test was done to assess the effect of the supplementations on ∆MPO and ∆pH. Multivariate quantile regression analysis was performed to analyze the association of the supplements with ∆MPO and ∆pH.ResultsIn comparison to the placebo group at day 10, a significant decrease in ∆MPO was found for the probiotic group (β-coefficient: -18.44; 95% CI: -31.62 µg/ml, -52.47 µg/ml; p = 0.007) and for the synbiotic group (β-coefficient: -17.24; 95% CI: -30.94 µg/ml, -35.36 µg/ml; p = 0.015). This reduction in ∆MPO in comparison to the placebo group was sustained only in the synbiotic group at other time points. Decrease in ∆pH was observed only in the synbiotic group at day 10 and day 28, but not at day 56 in comparison to the placebo group.ConclusionOur findings demonstrate that the use of this synbiotic supplementation may result in sustained effects in reduction of gut inflammation in young infants with SAM. However, further studies are required to fully evaluate the role of this synbiotic intervention for sustained reduction in fecal pH in this study population.Trial registrationThe trial is registered at ClinicalTrials.gov (NCT0366657). Registered on 12 September, 2018 (https://clinicaltrials.gov/ct2/show/NCT03666572)

Probiotics and prebiotics for severe acute malnutrition (PRONUT study): a double-blind efficacy randomised controlled trial in Malawi

The Lancet ◽  
2009 ◽  
Vol 374 (9684) ◽  
pp. 136-144 ◽  
Author(s):  
Marko Kerac ◽  
James Bunn ◽  
Andrew Seal ◽  
Mariam Thindwa ◽  
Andrew Tomkins ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Severe Acute Malnutrition ◽  
Controlled Trial ◽  
Acute Malnutrition ◽  
Double Blind ◽  
Randomised Controlled
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