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Efficacy of a Single Dose versus a Multiple Dose Regimen of Mebendazole against Hookworm Infections among School Children: a Randomized Open-label Trial
Tegegne Eshetu
University of Gondar College of Medicine and Health Sciences
Corresponding Author
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Background: Despite the existence of a population-based control program using single dose albendazole or mebendazole as a preventive chemotherapy, hookworm transmission remains high. It causes a negative impact on the growth and school performance of children. In connection to this preventive chemotherapy, different studies produced conflicting results. This study aimed at evaluating the efficacy of single (500mg) versus multiple doses (100mg twice a day during three consecutive days) of mebendazole against hookworm infections among school-aged children.
Methods: This randomized open-label clinical trial took place among school-aged children (6-14 years old) in Burie and Debre Elias towns, Northwest Ethiopia. Using simple randomization, eligible hookworm-positive children were allocated (1:1) to either a single or multiple dose treatment arms. Stool samples were collected and processed using McMaster method at baseline and follow-up period (14-21 days after treatment). Only laboratory technicians were blinded. The cure and egg reduction rates which were assessed after 14-21 days of treatment were the primary and secondary therapeutic outcome measures against hookworm infections, respectively. An independent t-test was used to compare group means, and logistic regression was used to calculate odds ratio (OR). P-value < 0.05 at 95% CI was considered statistically significant.
Result: 108 children, 54 in each treatment arm had completed baseline data and received allocated treatment. 103 children had completed follow-up data records and included for the final efficacy analysis. Cure rate against hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with OR=55.125; 95% CI: 11.92-254.9; P < 0.001. The egg reduction rate in the multiple dose treatment arm (99.5%) was also significantly higher than in the single dose arm (68.9%) with difference t (101) =5.38; 95% CI 230.95-505.36; P < 0.001.
Conclusion: The single dose regimen of mebendazole for the treatment of hookworm infections showed poor cure and egg reduction rates, while the multiple dose revealed satisfactory. Although multiple dose regimen administration is a bit more complex than the single dose, we strongly encourage replacing it with multiple dose regimen during deworming programs in hookworm endemic areas.
Trial registration: This trial is registered in www.pactr.org, # PACTR201911466695052.
Keywords
Hookworm, Single Dose, Multiple Dose, Mebendazole, Efficacy
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Review #2 received
Received 30 Mar, 2020
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Reviewers invited
Invitations sent on 27 Mar, 2020
Editor assigned
On 25 Mar, 2020
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On 24 Mar, 2020
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Editorial decision: Major revision
On 27 Feb, 2020
Reviewer #3 agreed
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Review #1 received
Received 10 Jan, 2020
Review #2 received
Received 10 Jan, 2020
Reviewer #2 agreed
On 10 Jan, 2020
Reviewers invited
Invitations sent on 09 Jan, 2020
Reviewer #1 agreed
On 09 Jan, 2020
Editor assigned
On 26 Dec, 2019
Submission checks complete
On 24 Dec, 2019
Editor invited
On 23 Dec, 2019
First submitted
On 06 Dec, 2019
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This preprint is under consideration at BMC Infectious Diseases. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Efficacy of a Single Dose versus a Multiple Dose Regimen of Mebendazole against Hookworm Infections among School Children: a Randomized Open-label Trial
Tegegne Eshetu
University of Gondar College of Medicine and Health Sciences
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 3
Posted 13 May, 2020
No community comments so far
Editor assigned
On 29 Apr, 2020
Editor invited
On 28 Apr, 2020
Submission checks complete
On 23 Dec, 2019
No comments provided
Editorial decision: Minor revision
On 16 Apr, 2020
Review #1 received
Received 14 Apr, 2020
Reviewer #2 agreed
On 30 Mar, 2020
Review #2 received
Received 30 Mar, 2020
Reviewer #1 agreed
On 28 Mar, 2020
Reviewers invited
Invitations sent on 27 Mar, 2020
Editor assigned
On 25 Mar, 2020
Submission checks complete
On 24 Mar, 2020
Editor invited
On 24 Mar, 2020
No comments provided
Editorial decision: Major revision
On 27 Feb, 2020
Reviewer #3 agreed
On 10 Feb, 2020
Review #1 received
Received 10 Jan, 2020
Review #2 received
Received 10 Jan, 2020
Reviewer #2 agreed
On 10 Jan, 2020
Reviewers invited
Invitations sent on 09 Jan, 2020
Reviewer #1 agreed
On 09 Jan, 2020
Editor assigned
On 26 Dec, 2019
Submission checks complete
On 24 Dec, 2019
Editor invited
On 23 Dec, 2019
First submitted
On 06 Dec, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Despite the existence of a population-based control program using single dose albendazole or mebendazole as a preventive chemotherapy, hookworm transmission remains high. It causes a negative impact on the growth and school performance of children. In connection to this preventive chemotherapy, different studies produced conflicting results. This study aimed at evaluating the efficacy of single (500mg) versus multiple doses (100mg twice a day during three consecutive days) of mebendazole against hookworm infections among school-aged children.
Methods: This randomized open-label clinical trial took place among school-aged children (6-14 years old) in Burie and Debre Elias towns, Northwest Ethiopia. Using simple randomization, eligible hookworm-positive children were allocated (1:1) to either a single or multiple dose treatment arms. Stool samples were collected and processed using McMaster method at baseline and follow-up period (14-21 days after treatment). Only laboratory technicians were blinded. The cure and egg reduction rates which were assessed after 14-21 days of treatment were the primary and secondary therapeutic outcome measures against hookworm infections, respectively. An independent t-test was used to compare group means, and logistic regression was used to calculate odds ratio (OR). P-value < 0.05 at 95% CI was considered statistically significant.
Result: 108 children, 54 in each treatment arm had completed baseline data and received allocated treatment. 103 children had completed follow-up data records and included for the final efficacy analysis. Cure rate against hookworm was significantly higher in the multiple dose (96.1%) than in the single dose (30.8%) with OR=55.125; 95% CI: 11.92-254.9; P < 0.001. The egg reduction rate in the multiple dose treatment arm (99.5%) was also significantly higher than in the single dose arm (68.9%) with difference t (101) =5.38; 95% CI 230.95-505.36; P < 0.001.
Conclusion: The single dose regimen of mebendazole for the treatment of hookworm infections showed poor cure and egg reduction rates, while the multiple dose revealed satisfactory. Although multiple dose regimen administration is a bit more complex than the single dose, we strongly encourage replacing it with multiple dose regimen during deworming programs in hookworm endemic areas.
Trial registration: This trial is registered in www.pactr.org, # PACTR201911466695052.
Figure 1