Comparison of 3 Days Amoxicillin Versus 5 Days Co-Trimoxazole for Treatment of Fast-breathing Pneumonia by Community Health Workers in Children Aged 2–59 Months in Pakistan: A Cluster-randomized Trial

Abstract Background Globally, most deaths due to childhood pneumonia occur at the community level. Some countries are still using oral co-trimoxazole, despite a World Health Organization recommendation of oral amoxicillin for the treatment of fast-breathing pneumonia in children at the community level. Methods We conducted an unblinded, cluster-randomized, controlled-equivalency trial in Haripur District, Pakistan. Children 2–59 months of age with fast-breathing pneumonia were treated with oral amoxicillin suspension (50 mg/kg/day) for 3 days in 14 intervention clusters and oral co-trimoxazole suspension (8 mg trimethoprim/kg and 40 mg sulfamethoxazole/kg/day) for 5 days in 14 control clusters by lady health workers (LHW). The primary outcome was treatment failure by day 4 for intervention clusters and by day 6 for control clusters. The analysis was per protocol. Results Out of the 15 749 cases enrolled in the study, 9153 cases in intervention and 6509 cases in control clusters were included in the analysis. Treatment failure rates were 3.6% (326) in intervention clusters and 9.1% (592) in control clusters. After adjusting for clustering, the risk of treatment failure was lower in intervention clusters (risk diﬀerence [RD] -5.5%, 95% confidence interval [CI] -7.4–-3.7%) than in control clusters. Children with incomplete adherence had a small increase in treatment failure versus those with complete adherence (RD 2.9%, 95% CI 1.6–4.1%). No deaths or serious adverse events occurred. Conclusions A 3-day course of oral amoxicillin, administered by LHWs, is an effective and safe treatment for fast-breathing pneumonia in children 2–59 months of age. A shorter course of amoxicillin improves adherence to therapy, is low in cost, and puts less pressure on antimicrobial resistance. Clinical Trials Registration ISRCTN10618300.

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Management of fast breathing pneumonia in young infants aged 7 to 59 days by community level health workers: protocol for a multi-centre cluster randomized controlled trial

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20201715 ◽

2020 ◽

Vol 7 (2) ◽

pp. 83 ◽

Cited By ~ 1

Author(s):

Yasir Bin Nisar

Keyword(s):

Health Workers ◽

Controlled Trial ◽

Community Level ◽

World Health ◽

Community Case Management ◽

Open Label ◽

Integrated Community Case Management ◽

Young Infants ◽

Oral Amoxicillin ◽

Cluster Randomized

Background: WHO does not recommend community-level health workers (CLHWs) using integrated community case management (iCCM) to treat 7-59 days old infants with fast breathing with oral amoxicillin, whereas World Health Organization (WHO) integrated management of childhood illness (IMCI) recommends it. We want to collect evidence to help harmonization of both protocols.Methods: A cluster, randomized, open-label trial will be conducted in Africa and Asia (Ethiopia, Malawi, Bangladesh and India) using a common protocol with the same study design, inclusion criteria, intervention, comparison, and outcomes to contribute to the overall sample size. This trial will also identify hypoxaemia in young infants with fast breathing. CLHWs will assess infants for fast breathing, which will be confirmed by a study supervisor. Enrolled infants in the intervention clusters will be treated with oral amoxicillin, whereas in the control clusters they will be managed as per existing iCCM protocol. An independent outcome assessor will assess all enrolled infants on days 6 and 14 of enrolment for the study outcomes in both intervention and control clusters. Primary outcome will be clinical treatment failure by day 6. This trial will obtain approval from the WHO and site institutional ethics committees.Conclusions: If the research shows that CLHWs can effectively and safely treat fast breathing pneumonia in 7-59 days old young infants, it will increase access to pneumonia treatment substantially for infants living in communities with poor access to health facilities. Additionally, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with IMCI protocol.Trial Registration: The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303.

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Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma

BMC Ophthalmology ◽

10.1186/s12886-020-01776-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Abdou Amza ◽

Boubacar Kadri ◽

Beido Nassirou ◽

Ahmed M. Arzika ◽

Ariana Austin ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Clinical Signs ◽

Cluster Randomized Trial ◽

World Health ◽

Baseline Assessment ◽

Randomized Controlled ◽

Registration Number ◽

Cluster Randomized ◽

Health Organization

Abstract Background The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation—follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether mass azithromycin distribution can be stopped prior to the current WHO guidelines. Methods The Azithromycin Reduction to Reach Elimination of Trachoma (ARRET) study is a 1:1 community randomized non-inferiority trial designed to evaluate whether mass azithromycin distribution can be stopped in districts with baseline prevalence of TF under 20%. Communities in Maradi, Niger are randomized after baseline assessment either to continued annual mass azithromycin distribution or stopping annual azithromycin distribution over a 3-year period. We will compare the prevalence of ocular C. trachomatis (primary outcome), TF and other clinical signs of trachoma, and serologic markers of trachoma after 3 years. We hypothesize that stopping annual azithromycin distribution will be non-inferior to continued annual azithromycin distributions for all markers of trachoma prevalence and transmission. Discussion The results of this trial are anticipated to provide potentially guideline-changing evidence for when mass azithromycin distributions can be stopped in low TF prevalence areas. Trial registration number This study is registered at clinicaltrials.gov (NCT04185402). Registered December 4, 2019; prospectively registered pre-results.

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Insecticide resistance characteristic of Anopheles vector species successfully controlled by deployment of pyrethroid and PBO long lasting insecticidal treated nets (LLINs) in Tanzania

10.1101/2021.03.19.436139 ◽

2021 ◽

Author(s):

Johnson Matowo ◽

David Weetman ◽

Patricia Pignatell ◽

Alexandra Wright ◽

Jacques Charlwood ◽

...

Keyword(s):

Insecticide Resistance ◽

Pyrethroid Resistance ◽

Cluster Randomized Trial ◽

World Health ◽

Malaria Vectors ◽

Metabolizing Enzymes ◽

Sub Saharan ◽

Underlying Mechanisms ◽

Cluster Randomized ◽

Health Organization

Long lasting insecticidal nets (LLINs) are a proven tool to reduce malaria transmission, but in Africa efficacy is being reduced by pyrethroid resistance in the major vectors. A cluster randomized trial in Muleba district, Tanzania demonstrated that permethrin LLINs co-treated with piperonyl butoxide (PBO), a synergist that can block pyrethroid-metabolizing enzymes in the mosquito, had much greater efficacy than pyrethroid-only nets. Insecticide resistance profiles and underlying mechanisms were investigated in Anopheles gambiae and An. funestus from Muleba during the trial. Diagnostic dose bioassays using permethrin, together with intensity assays, suggest pyrethroid resistance that is both strong and very common, but not extreme. Transcriptomic analysis found multiple P450 genes over expressed including CYP6M2, CYP6Z3, CYP6P3, CYP6P4, CYP6AA1 and CYP9K1 in An. gambiae and CYP6N1, CYP6M7, CYP6M1 and CYP6Z3 in An. funestus. Indeed, very similar suites of P450 enzymes commonly associated with resistant populations elsewhere in Africa were detected as over expressed suggesting a convergence of mechanisms across Sub-Saharan African malaria vectors. The findings give insight into factors that may correlate with pyrethroid PBO LLIN success, broadly supporting model predictions, but revision to guidelines previously issued by the World Health Organization is warranted.

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Simplifying the World Health Organization Protocol: 3 Steps Versus 6 Steps for Performance of Hand Hygiene in a Cluster-randomized Trial

Clinical Infectious Diseases ◽

10.1093/cid/ciy948 ◽

2018 ◽

Vol 69 (4) ◽

pp. 614-620 ◽

Cited By ~ 6

Author(s):

Sarah Tschudin-Sutter ◽

Daniel Sepulcri ◽

Marc Dangel ◽

Anja Ulrich ◽

Reno Frei ◽

...

Keyword(s):

Hand Hygiene ◽

Randomized Trial ◽

World Health Organization ◽

Cluster Randomized Trial ◽

Interquartile Range ◽

World Health ◽

Bacterial Colony ◽

Bacterial Counts ◽

Cluster Randomized ◽

Health Organization

Abstract Background In an experimental setting, a simplified, 3-step hand hygiene technique for applying alcohol-based hand rub was non inferior in terms of reduction of bacterial counts, as compared to the conventional World Health Organization 6-step technique. We therefore compared compliance and microbiological efficacy between both hand hygiene techniques in routine clinical practice. Methods We performed a cluster-randomized trial from October–November 2015 at the University Hospital Basel, Switzerland: a tertiary, academic care center (ISRCTN45923734). We randomly assigned 12 wards to either the 3-step technique or the conventional 6-step technique of hand rubbing. The primary endpoints were compliance with the assigned technique and reduction of bacterial counts on the hands of health-care workers. Results Overall, 2923 hand hygiene indications were observed, and compliance was 70.7% (2066/2923). Compliance with technique and indications was 51.7% (595/1151) and 75.9% (1151/1516) on wards assigned to the 3-step technique, respectively, as compared to 12.7% (116/915) and 65.0% (915/1407) on wards assigned to the 6-step technique (P < .001). The reduction factor (RF) of bacterial colony counts did not differ between techniques (median RF 0.97 log10 colony-forming units [CFU] [interquartile range 0.39–1.59] for the 3-step technique vs median RF 1.04 log10 CFU [interquartile range 0.49–1.52] for the 6-step technique; P = .629). Conclusions In a clinical setting, the simpler hand hygiene technique, consisting of 3 steps, resulted in higher compliance with both hand hygiene indications and technique, as compared to the 6 steps. As the results of the microbiological analyses exclude inferiority, the conventional 6 steps could be safely replaced by a simpler hand hygiene technique. Clinical Trials Registration ISRCTN45923734.

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Effectiveness and implementation of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster Randomized Controlled Trial SMS reminders and tailored feedback through evriMED and adherence to TB treatment

10.21203/rs.2.399/v2 ◽

2019 ◽

Author(s):

I. Marion Sumari-de Boer ◽

Francis M Pima ◽

Kennedy M Ngowi ◽

Geoffrey M Chelangwa ◽

Linda Minja ◽

...

Keyword(s):

Controlled Trial ◽

Care Facility ◽

Health Care Facility ◽

Cluster Randomized Trial ◽

World Health ◽

Tb Treatment ◽

Sms Reminders ◽

Cluster Randomized ◽

Health Organization ◽

Monitoring Technologies

Abstract Background: Adherence to Tuberculosis (TB) treatment is challenging because of many factors. The World Health Organization (WHO) has recommended the use of digital adherence monitoring technologies in its End-TB-strategy. However, there is paucity on its evidence in improving adherence. EvriMED is a real time medication monitoring (RTMM) device which was found feasible and acceptable in few studies in Asia. However, in Tanzania, there may be challenges in implementing evriMED due to stigmatization, network and power access, accuracy and cost effectiveness which may have an implication for treatment outcomes. We propose a pragmatic cluster randomized trial, to investigate the effectiveness of evriMED with reminder cues and tailored feedback on adherence to TB treatment in Kilimanjaro, Tanzania. Methods: We will create clusters in Kilimanjaro based on level of health care facility. Clusters will be randomized in an intervention arm, where evriMED will be implemented or a control arm, where standard practice Directly Observed Treatment (DOT) will be followed. TB patients in intervention clusters will take their medication from the evriMED pillbox and receive tailored feedback. We will use the ‘Stagesof-change’model, which assumes that a person has to go through the stages of pre-contemplation, contemplation, preparation, action and evaluation to change behaviour for tailored feedback on adherence reports from the device. Discussion: If the intervention shows a significant effect on adherence and the devices are accepted, accurate and sustainable, the intervention can be scaled up within the National Tuberculosis Programmes. Trial registration: PACTR201811755733759 at 8 November 2018 at https://pactr.samrc.ac.za/

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Community case management of chest indrawing pneumonia in children aged 2 to 59 months by community health workers: study protocol for a multi-country cluster randomized open label non-inferiority trial

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20201719 ◽

2020 ◽

Vol 7 (2) ◽

pp. 131

Author(s):

Yasir Bin Nisar

Keyword(s):

Case Management ◽

Health Facility ◽

Health Workers ◽

Intervention Group ◽

World Health ◽

Control Group ◽

Community Case Management ◽

Open Label ◽

Oral Amoxicillin ◽

Cluster Randomized

Background: The World Health Organization (WHO) integrated management of childhood illness (IMCI) protocol recommends treatment of chest indrawing in 2-59 months old children with oral amoxicillin by trained health facility workers. Whereas, the WHO/UNICEF integrated community case management (iCCM) protocol recommends referral by community level health workers (CLHWs) to a health facility. This study aims to evaluate whether CLHWs can treat chest indrawing pneumonia effectively and safely.Methods: This multi-centre cluster randomized controlled open label, non-inferiority trial will be conducted in Bangladesh, Ethiopia, India and Malawi. All sites will use a common protocol with the same study design, participants, intervention, control and outcomes. CLHWs will identify 2-59 months old children with chest indrawing. Study supervisors, trained in the iCCM protocol, will confirm CLHWs’ findings. Pulse oximetry will be used to identify hypoxaemic children. In the intervention group, enrolled children will be treated with oral amoxicillin for 5 days, and in the control group they will be referred to a health facility, after providing first dose of oral amoxicillin. An independent outcome assessor will visit each enrolled child on days 6 and 14 of enrolment, to assess study outcomes.Conclusions: If CLHWs can effectively and safely treat chest indrawing pneumonia in 2-59 months old children, it will increase access to pneumonia treatment substantially, as in many settings, health facilities and trained health workers are not easily accessible. Moreover, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with the IMCI protocol.Trial Registration: The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303.

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Faculty Opinions recommendation of Effect of the World Health Organization checklist on patient outcomes: a stepped wedge cluster randomized controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718387567.793496784 ◽

2014 ◽

Author(s):

M Rashad Massoud

Keyword(s):

Randomized Controlled Trial ◽

World Health Organization ◽

Patient Outcomes ◽

Controlled Trial ◽

World Health ◽

Stepped Wedge ◽

Randomized Controlled ◽

The World ◽

Cluster Randomized ◽

Health Organization

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Effect of Peer Health Workers on AIDS Care in Rakai, Uganda: A Cluster-Randomized Trial

PLoS ONE ◽

10.1371/journal.pone.0010923 ◽

2010 ◽

Vol 5 (6) ◽

pp. e10923 ◽

Cited By ~ 109

Author(s):

Larry W. Chang ◽

Joseph Kagaayi ◽

Gertrude Nakigozi ◽

Victor Ssempijja ◽

Arnold H. Packer ◽

...

Keyword(s):

Randomized Trial ◽

Health Workers ◽

Cluster Randomized Trial ◽

Cluster Randomized

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Edukasi dan Deteksi Dini Komplikasi Kehamilan dengan Pemeriksaan Laboratorium

Poltekita: Jurnal Pengabdian Masyarakat ◽

10.33860/pjpm.v1i2.98 ◽

2020 ◽

Vol 1 (2) ◽

pp. 43-49

Author(s):

Rochany Septiyaningsih ◽

Dhiah Dwi Kusumawati ◽

Frisca Dewi Yunadi ◽

Septiana Indratmoko

Keyword(s):

Pregnant Women ◽

Health Workers ◽

World Health ◽

Maternal Deaths ◽

Middle Income ◽

Pregnancy And Childbirth ◽

Delivery Assistance ◽

The World ◽

Laboratory Examinations ◽

Health Organization

The World Health Organization (WHO) states that maternal mortality worldwide due to complications during pregnancy and childbirth in 2017 is estimated at around 810 cases. Between 2000 and 2017 there was a decline in the ratio of MMR around the world by 38%. WHO also states that 94% of global maternal deaths occur in low and middle income countries. In Indonesia, maternal deaths due to complications from pregnancy or childbirth every year are estimated at 20,000 mothers died from five million births. Delivery assistance by trained health workers in health facilities can be an effort to reduce MMR and IMR. In addition, awareness of pregnant women is also important for the importance of having a pregnancy with a health worker. This community service aims to increase the knowledge of pregnant women about anemia and to detect early pregnancy complications by laboratory examinations. The target of this activity is 15 pregnant women. The dedication activity is conducting educational activities, laboratory examinations in Tambakreja Village, Cilacap Regency. Based on the results of this activity it was concluded that there was an increase in knowledge of pregnant women about anemia and found 2 pregnant women experiencing anemia from 15 pregnant women and urine examination found all negative pregnant women

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