Assessment of Drug Efficacy of Local Albendazole

NCT02420574 | Completed

• 1 other identifier: B670201319330
• Study Type: interventional
• Target: 679
• Locations: 0 countries
• Sites: N/A

Brief Summary

Infections with soil-transmitted helminthes (STH) occur throughout the developing world and remain a major public health problem in the poorest communities. Preventive chemotherapy (PC) programs in which single-dose albendazole 400 mg or single-dose mebendazole 500 mg - the drugs of choice for STH - are administered at the population level, is the main strategy for STH control. To ensure quality, these drugs are being widely donated by GlaxoSmithKline (GSK) (albendazole (ALB), Zentel) and Johnson \& Johnson (mebendazole (MEB), Vermox). In addition to this, there are a wide variety of ALB and MEB tablets available on the local market. Although little is known about the quality of anthelmintics sold for human use, several publications have reported variability in the quality of generic anthelmintics used in veterinary medicine. The main objective of the present study is to compare the efficacy of two ALB brands bought on the local market, including OVIS (Korea, DAEHWA pharmaceutical) and BENDEX (India, Cipla)

Conditions

Helminthiasis

Outcome Measures

Primary Outcomes (1)

• Egg reduction rate

  14 days after administration of the drugs

Study Arms (2)

ALB-BENDEX

ACTIVE COMPARATOR

albendazole, 400 mg, single oral dose, (BENDEX)

Drug: albendazole BENDEX

ALB-OVIS

ACTIVE COMPARATOR

albendazole, 400 mg, single-oral dose, (OVIS)

Drug: albendazole OVIS

Interventions

albendazole BENDEX DRUG

randomized clinical trial with 2 parallel arms

Also known as: BENDEX/OVIS

ALB-BENDEX

albendazole OVIS DRUG

ALB-OVIS

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 5-18 years old.
• Sex: males and females.
• Signed of written informed consent sheet by parents/or guardians, and those who volunteered to comply with study procedures (stool submission, drug treatment).
• Females: was not pregnant (as verbally assessed by clinician upon enrolled to treatment).

You may not qualify if:

• Had vomit within 4 hours after drug administration.
• Had diarrhea at time of the first sampling.
• Subjects who were unable to provide a stool sample at follow-up,
• Subjects who experienced a severe concurrent medical condition
• Subjects with known history of allergic reaction to ALB.

Sponsors & Collaborators

• University Ghent: lead

Related Publications (10)

• Bethony J, Brooker S, Albonico M, Geiger SM, Loukas A, Diemert D, Hotez PJ. Soil-transmitted helminth infections: ascariasis, trichuriasis, and hookworm. Lancet. 2006 May 6;367(9521):1521-32. doi: 10.1016/S0140-6736(06)68653-4.

  PMID: 16679166 BACKGROUND

• Bundy DA, Hall A, Medley GF, Savioli L. Evaluating measures to control intestinal parasitic infections. World Health Stat Q. 1992;45(2-3):168-79.

  PMID: 1462652 BACKGROUND

• Crompton DW, Nesheim MC. Nutritional impact of intestinal helminthiasis during the human life cycle. Annu Rev Nutr. 2002;22:35-59. doi: 10.1146/annurev.nutr.22.120501.134539. Epub 2002 Jan 4.

  PMID: 12055337 BACKGROUND

• Curtale F, Pokhrel RP, Tilden RL, Higashi G. Intestinal helminths and xerophthalmia in Nepal. A case-control study. J Trop Pediatr. 1995 Dec;41(6):334-7. doi: 10.1093/tropej/41.6.334.

  PMID: 8606439 BACKGROUND

• De Clercq D, Sacko M, Behnke J, Gilbert F, Dorny P, Vercruysse J. Failure of mebendazole in treatment of human hookworm infections in the southern region of Mali. Am J Trop Med Hyg. 1997 Jul;57(1):25-30. doi: 10.4269/ajtmh.1997.57.25.

  PMID: 9242313 BACKGROUND

• Monteiro AM, Wanyangu SW, Kariuki DP, Bain R, Jackson F, McKellar QA. Pharmaceutical quality of anthelmintics sold in Kenya. Vet Rec. 1998 Apr 11;142(15):396-8. doi: 10.1136/vr.142.15.396.

  PMID: 9586132 BACKGROUND

• Nokes C, Bundy DA. Does helminth infection affect mental processing and educational achievement? Parasitol Today. 1994 Jan;10(1):14-8. doi: 10.1016/0169-4758(94)90348-4.

  PMID: 15275558 BACKGROUND

• Stephenson LS, Latham MC, Adams EJ, Kinoti SN, Pertet A. Physical fitness, growth and appetite of Kenyan school boys with hookworm, Trichuris trichiura and Ascaris lumbricoides infections are improved four months after a single dose of albendazole. J Nutr. 1993 Jun;123(6):1036-46. doi: 10.1093/jn/123.6.1036.

  PMID: 8505663 BACKGROUND

• Stoltzfus RJ, Albonico M, Chwaya HM, Savioli L, Tielsch J, Schulze K, Yip R. Hemoquant determination of hookworm-related blood loss and its role in iron deficiency in African children. Am J Trop Med Hyg. 1996 Oct;55(4):399-404. doi: 10.4269/ajtmh.1996.55.399.

  PMID: 8916795 BACKGROUND

• Vercruysse J, Behnke JM, Albonico M, Ame SM, Angebault C, Bethony JM, Engels D, Guillard B, Nguyen TV, Kang G, Kattula D, Kotze AC, McCarthy JS, Mekonnen Z, Montresor A, Periago MV, Sumo L, Tchuente LA, Dang TC, Zeynudin A, Levecke B. Assessment of the anthelmintic efficacy of albendazole in school children in seven countries where soil-transmitted helminths are endemic. PLoS Negl Trop Dis. 2011 Mar 29;5(3):e948. doi: 10.1371/journal.pntd.0000948.

  PMID: 21468309 BACKGROUND

Related Links

• World Health Organization (2005) Deworming for health and development. Report of the third global meeting of the partners for parasitic control. WHO/CDS/CPE/PVC/2005.14, World Health Organization, Geneva.
• 6\. Kumsa, B., Debela, E., Megersa, B., 2010. Comparative efficacy of albendazole, tetramisole and ivermectin against gastrointestinal nematodes in naturally infected goats in Ziway, Oromia Regional State (Southern Ethiopia). J Anim Vet Adv 9, 2905-2911.

MeSH Terms

Conditions

Helminthiasis

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections

Study Officials

• Jozef Vercruysse, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 20, 2015
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: February 1, 2015
• Last Updated: December 9, 2022

Record last verified: 2022-12