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Kilimanjaro IPTi Drug Options Trial

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ClinicalTrials.gov Identifier: NCT00158574
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 12, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP.

This study objectives are:

  1. Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine.
  2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi.
  3. Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi.
  4. Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas.

A randomised trial with four treatment regimes is proposed which will be conducted in two different transmission settings. The four treatment regimens are as follows: (1) placebo; (2) mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is the incidence of clinical malaria.


Condition or disease Intervention/treatment Phase
Malaria Drug: sulphadoxine-pyrimethamine Drug: mefloquine Drug: Chlorproguanil-dapsone Drug: Placebo Drug: Sulphadoxine-pryrimethamine Drug: IPTi mefloquine Drug: Chlorproguanil dapsone Phase 2 Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2419 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Drug Options for Intermittent Preventive Treatment for Malaria in Infants in an Area With High Resistance to Sulfadoxine/Pyrimethamine: an Evaluation of Short and Long-acting Antimalarial Drugs
Study Start Date : January 2005
Primary Completion Date : April 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
IPTi placebo
Drug: Placebo
Placebo
Experimental: Sulphadoxine-pyrimethamine
IPTi SP
Drug: sulphadoxine-pyrimethamine
Other Name: Fansidar
Drug: Sulphadoxine-pryrimethamine
IPTi doses 1 and 2, at ages 2 and 3 months, sulphadoxine 250mg, pyrimethamine 12.5mg IPTi doses 3, at 9 months of age, sulphadoxine 500mg, pyrimethamine 25mg
Other Name: Fansidar
Experimental: Mefloquine Drug: mefloquine
Other Name: Larium
Drug: IPTi mefloquine
IPTi doses 1 & 2 at ages 2 & 3 months, mefloquine 125mg IPTi dose 3 at 9 months, mefloquine 250mg
Other Name: Larium
Experimental: Chlorproguanil dapsone Drug: Chlorproguanil-dapsone
Other Name: Lapdap
Drug: Chlorproguanil dapsone
IPTi doses 1 and 2 at ages 2 and 3 months, doses 15mg chlorproguanil and 18.75mg dapsone IPTi dose 3 at 9 months of age, doses 22.5mg chlorproguanil and 28.13mg dapsone
Other Name: Lapdap


Outcome Measures

Primary Outcome Measures :
  1. 1. Incidence of clinical malaria: [(history of fever during previous 2 days or axillary temperature >37.5ºC) + parasitaemia of any density + absence of any other obvious causes of fever] during the period of 3-11 months of age [ Time Frame: 3-11 months of age ]

Secondary Outcome Measures :
  1. 1.Mean Hb at 10-12 months of age (one month after the third course of IPTi) [ Time Frame: 10-12 months of age ]
  2. 2.Incidence of severe anaemia (Hb <7 g/dl) during the period of 3-11 months of age [ Time Frame: 3-11 months of age ]
  3. 3.Prevalence of parasitaemia at 10-12 months of age (one month after the third course of IPTi) [ Time Frame: 10-12 months of age ]
  4. 4.Incidence of clinical malaria [as defined above] during the period of 12-23 months of age. [ Time Frame: 12-23 months of age ]
  5. 5.Level and repertoires of plasma antibodies to Plasmodium falciparum variant surface antigen (anti-VSA antibodies) at 10 and 18 months of age. [ Time Frame: 10 and 18 months of age ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All infants attending EPI clinics at the 12 study health facilities for first vaccinations. Infants who live within the catchment area of the study health facility and are less than 3 months of age at the time of DPT and Polio 1 vaccination will be eligible for inclusion in the study.

Exclusion Criteria:

  • Infants having any of the following conditions will be excluded: (1) history of allergy to study drugs; (2) history of convulsions; (3) clinical features of severe malnutrition or chronic illness including infants with signs of AIDS [HIV prevalence in women of reproductive age in the study area was 11.5% in 1999]39 (4) plans to leave the study area before 12 months of age.(5) weighs <4.5 kgs (6) caretaker declines to give consent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158574


Locations
Tanzania
Ministry of Health, Korogwe and Same District MCH clinics
Tanga, Tanga and Kilimanjaro, Tanzania
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University of Copenhagen
National Institute for Medical Research, Tanzania
Kilimanjaro Christian Medical Centre, Tanzania
Investigators
Study Director: Roly Gosling, MBChB, MRCP London School of Hygiene and Tropical Medicine
Principal Investigator: Daniel Chandramohan, MBBS,PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Brian Greenwood, FRCP, FRS London School of Hygiene and Tropical Medicine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00158574     History of Changes
Other Study ID Numbers: ITDCVF01
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
intermittent preventive treatment
malaria
efficacy
safety
drug options

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Dapsone
Fanasil, pyrimethamine drug combination
Mefloquine
Chlorproguanil
Proguanil
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Leprostatic Agents
Anti-Bacterial Agents
Antimetabolites